<h3>Job Description</h3>
Salary: 
Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.

Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company has completed an initial public offering (IPO) in February of 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.

POSITION SUMMARY
Structure Therapeutics is seeking a highly motivated Clinical Trial Manager (CTM) to be part of our Clinical Operations team.   This is a unique opportunity to join a growing company committed to converting biologics and peptides into life-changing small molecule medicines for everyone. The CTM will be responsible for the day-to-day oversight of global clinical trials and will manage internal stakeholders, CROs, multiple service providers, clinical monitors, and clinical trial sites. The CTM will focus on the management and support of multinational, multicenter, Phase II studies and may assume responsibility for additional studies/indications as applicable. The CTM works closely with and supports the Clinical Development Operations team, receives assignments in the form of objectives, and will ensure deliverables are completed on time and within budget.#Hybrid.

This position will also work closely with a cross-functional team based in the US and Shanghai to ensure that clinical trials are conducted in a timely fashion and compliant with SOPs, ICH/GCP, Country specific regulatory guidelines, company goals, and budgets. The CTM will be responsible for managing various project goals and supporting delivery of a quality clinical trial to meet current business needs and trends.

ESSENTIAL DUTIES AND RESPONSIBILITIES 
<ul>
<li> Leads and coordinates global cross-functional study teams through all study stages (start-up, conduct, close-out).</li>
<li> In collaboration with internal stakeholders, responsible for helping to drive the RFP and RFI process, analyze service providers, budgets and proposals, conduct bid defense meetings, award services, negotiate and execute complex agreements (i.e., CRO, study related collaboration agreements).</li>
<li> Provides oversight and direction to the CRO and service providers to accurately coordinate clinical study activities.</li>
<li> Assists with Inspection Readiness activities which may require the development, modification and/or implementation of policies as needed to ensure high quality and integrity in all study activities.</li>
<li> Coordinate clinical study timelines with Project management and escalate issues that may impact timelines/ deliverables.</li>
<li> Leads and/or participates in the development and review of study documents including, but not limited to, CRF design, project plans, Service Provider Oversight plans, TMF plan.</li>
<li> Follows processes and procedures and recommend changes to SOP’s and policies to ensure comprehensive and compliant processes in the clinical operations organization.</li>
<li> Identifies potential study issues/risks, escalates as needed and recommends/implements</li>
<li> Manages study sites and study related activities including but not limited to site feasibility, selection, start up, subject recruitment, enrollment, study management, monitoring report review, site management, trial master files, and data review/clean up.</li>
<li> Coordinate with Lead and Finance to track the financial status against budget. </li>
<li> Provide regular updates to Study Lead and other stakeholders; Proactively identify, manage, or escalate issues appropriately.</li>
<li> Prepares or reviews clinical sections of regulatory submission documents, responses to EC and/or Health Authority questions.</li>
<li> Monitors study progress for possible changes in study scope to ensure timely change order implementation and finalization; implementation of PI Training, site monitor training, etc.</li>
<li> May have some responsibility for the oversight and management of the study budget including site and service provider budgets.</li>
<li> Supervises ongoing communication of operational issues and provides accurate progress reports on assigned activities to Study Management Team and Clinical Development Team.</li>
<li> Ensures oversight of data and information in study specific systems EDC, CTMS, eTMF is current and accurate.</li>
<li> May lead a cooperative effort on a project team or contribute as a subject matter expert on key projects and initiatives to identify and implement process improvements and standards.</li>
<li> Other supportive duties as assigned to achieve operational</li>
</ul>

COMMUNICATION &amp; INTERPERSONAL SKILLS
<ul>
<li> Must have high quality written and oral communication skills, with the ability to convey overall objectives and maintain open lines of communication between the internal stakeholders and service providers.</li>
<li> Must have negotiation and project management skills with the ability to coordinate across projects/program/timelines.</li>
<li> Ability to integrate into and collaborate effectively with a remote cross-functional team environment (US, APAC, EU) with a positive attitude.</li>
<li> Ability to prioritize and handle multiple activities daily yet flexible and responsive to frequently shifting priorities.</li>
<li> Models our core values: Passion, Integrity, Innovation, and Patient Focus</li>
</ul>

CORE COMPETENCIES, KNOWLEDGE AND SKILL REQUIREMENTS
<ul>
<li> PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)</li>
<li> In-depth understanding of FDA and EU regulations, ICH Guidelines and GCP requirements governing the conduct of clinical trials.</li>
<li> Hybrid schedule requiring flexibility to be onsite 3 days week in our SSF, CA office</li>
</ul>

REQUIREMENTS
Education
<ul>
<li> Bachelor’s degree or equivalent (scientific or healthcare discipline preferred)</li>
</ul>
Experience
<ul>
<li> Minimum of 5-7+ years of related industry experience as a Clinical Research Associate or related function with increasing responsibility and scope</li>
<li> Minimum of 3 years study management experience in clinical and drug development</li>
<li> Experience in selecting, managing, and overseeing sites, CROs, specialty labs and other service providers in global, multinational studies or programs.</li>
<li> Experience in supporting SOP development and implementation is</li>
<li> Experience working on global teams is desired, Asia-Pacific and EU highly</li>
</ul>
Travel - up to 30%

The target salary range for this full-time role is $140,000 to $155,000+ bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.

Clinical Trial Manager

<h3>Job Description</h3>
Salary: $62,000 - $72,000
We are looking for a Clinical Trial Manager I to join our team!
Are you well organized and adaptable to unexpected changes? Someone who is able to see the bigger picture, without losing sight of the day-to-day tasks? If the answer is yes, keep reading!
Clinical Trial Manager I serves as the primary point of contact for clinical trials site operations. 

Remote candidates are welcome to apply.
In this position you will:
<ul>
<li> Serve as the secondary contact to address site questions when the site Clinical Research Associate (CRA) or Research Assistant (RA) is unavailable. </li>
<li> Ensure CPC SOPs, Good Clinical Practice guidelines and applicable federal, state and local regulations are being followed.</li>
<li> Review monitoring visit reports and follow-up letters for Site Endpoint Evaluation Visits, Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits and Addendums and work with CRAs to clarify issues and finalize reports and follow-up letters.</li>
<li> Review site specific Informed Consent Forms (ICFs) to address site specific changes and escalate to internal or external parties for approval, as needed.</li>
<li> Provide the Project Manager with metrics and updates on sites including but not limited to: study related site enrollment, site activations, protocol deviations, monitoring reports and follow-up letters status.</li>
<li> Assure proper maintenance of site required records for monitoring activities and required regulatory documents per CPC requirements. </li>
<li> Create and/or review study-specific monitoring visit reports and, follow-up letter templates, and project specific site materials including Monitoring Plans, ICF templates, Study Procedure Manual, source document and site newsletter.</li>
<li> Work with CRAs, RAs and Clinical Trial Managers on overall site management including identification, escalation and resolution of site related compliance issues. </li>
<li> Support Investigational Product (IP) release and once IP release has occurred, work with the RAs to collect all new or expiring Investigator regulatory documents.</li>
<li> Support site activations and IP release. </li>
<li> Participate in project-related and other departmental/CPC meetings as required.</li>
<li> Assist with the selection of qualified sites and Investigators for participation in research protocols.</li>
<li> Assist with negotiation of study site budget. Oversee tracking, request and work with the Finance department on processing study site payments.</li>
<li> Attend project team meetings as necessary and provide CRAs with updated study information to support their monitoring activities.</li>
<li> Work closely with other team members to ensure timely resolution of site issues.</li>
<li> Conduct drug tracking and disposition as required by project. </li>
<li> Assist in oversight of remote monitoring. </li>
<li> Ensure Clinical Trial Management System (CTMS) remains up to date with all site trial activities including but not limited to site communications, document status, monitoring visits, protocol deviations. </li>
<li> Conduct site monitoring visits or co-monitoring visits, as needed. </li>
<li> Additional duties as required.</li>
</ul>
Here’s what you will need to bring to the table:

<ul>
<li>Nursing or bachelor’s degree preferred.</li>
<li> A minimum of 2 years of experience in clinical research setting required, experience in monitoring or clinical trial management preferred. </li>
<li> Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials. </li>
<li> Thorough understanding of the drug development process.</li>
<li> Proficiency in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint).</li>
<li> Experience with electronic data capture systems.</li>
<li> Excellent interpersonal communication skills, organizational skills and a great attention to detail. </li>
<li> Ability to organize and instruct staff, while promoting group effort and achievement.</li>
<li> Ability to carry out multiple tasks simultaneously.</li>
<li> Ability to complete tasks in an accurate and timely manner.</li>
<li> Ability to manage conflicts and resolve problems effectively.</li>
<li> Ability to discern priorities with minimal direction to accomplish day-to-day tasks.</li>
<li>Willingness to travel up to 25% of the time.</li>
</ul>
Note: Viable applicants will be required to pass a background and education verification check.
Targeted Compensation: $62,000 - $72,000 annually

Deadline to Apply: May 1, 2024

About CPC:

CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more. 
CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.
CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. <a href="http://www.cpccommunityhealth.org/" target="_blank">http://www.cpccommunityhealth.org/</a>
CPC offers:

<ul>
<li> Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)</li>
<li> Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)</li>
<li> 11 paid holidays</li>
<li>15 - 25 vacation days based on years of service</li>
<li>Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) </li>
<li> In-suite exercise and relaxation room</li>
<li> Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)</li>
<li> Flexible and remote work schedules</li>
</ul>
An Equal Opportunity Employer

CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.
Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at <a href="mailto:careers@cpcmed.org" target="_blank">careers@cpcmed.org</a>.
remote work

Clinical Trial Manager I

<h3>Job Description</h3>
Salary: 
Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.
Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company has completed an initial public offering (IPO) in February of 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.

POSITION SUMMARY
Structure Therapeutics is seeking a highly motivated Clinical Trial Manager (Sr. CTM) to be a part of our Clinical Operations team.  This is a unique opportunity to join a growing company committed to converting biologics and peptides into life-changing small molecule medicines for everyone. The Sr. CTM will be responsible for the day-to-day oversight of global clinical trials and will manage internal stakeholders, CROs, multiple service providers, clinical monitors, and clinical trial sites. The Sr. CTM will focus on the management and support of multinational, multicenter, Phase II studies and may assume responsibility for additional studies/indications as applicable. The Sr. CTM works closely with and supports the Clinical Development Operations team, receives assignments in the form of objectives, and will ensure deliverables are completed on time and within budget.

This position will also work closely with a cross-functional team based in the US and Shanghai to ensure that clinical trials are conducted in a timely fashion and compliant with SOPs, ICH/GCP, Country specific regulatory guidelines, company goals, and budgets. The Sr. CTM will be responsible for managing various project goals and supporting delivery of a quality study to meet current business needs and trends.#hybrid. 

ESSENTIAL DUITES AND RESPONSIBILITIES
<ul>
<li> Leads and coordinates global cross-functional study teams through all study stages (start-up, conduct, close-out). </li>
<li> In collaboration with internal stakeholders, responsible for helping to drive the RFP and RFI process, analyze service providers, budgets and proposals, conduct bid defense meetings, award services, negotiate and execute complex agreements (i.e., CRO, study related collaboration agreements). </li>
<li> Provides oversight and direction to the CRO and service providers to accurately coordinate clinical study activities. </li>
<li> Assists with Inspection Readiness activities which may require the development, modification and/or implementation of policies as needed to ensure high quality and integrity in all study activities. </li>
<li> Coordinate clinical study timelines with Project management and escalate issues that may impact timelines/ deliverables. </li>
<li> Leads and/or participates in the development and review of study documents including CRF design, project plans, Service Provider Oversight plans, TMF (Trial Master File) plan. </li>
<li> Follows processes and procedures and recommend changes to SOP’s and policies to ensure comprehensive and compliant processes in the clinical operations organization. </li>
<li> Identifies potential study issues/risks, escalates as needed and recommends/implements solutions. </li>
<li> Manages study sites and study related activities including but not limited to site feasibility, selection, start up, subject recruitment, enrollment, study management, monitoring report review, site management, trial master files, and data review / clean up. </li>
<li> Provide regular updates to Study lead and other stakeholders; Proactively identify, manage, or escalate issues appropriately. </li>
<li> Coordinate with Study Lead and Finance to track vendor accruals and financial status against budget</li>
<li> Prepares or reviews clinical sections of regulatory submission documents, responses to EC and/or Health Authority questions.</li>
<li> Monitors study progress for possible changes in study scope to ensure timely change order. </li>
<li> May have some responsibility for the oversight and management of the study budget including site and service provider budgets. </li>
<li> Supervises ongoing communication of operational issues and provides accurate progress reports on assigned activities to Study Management Team and Clinical Development Team. </li>
<li> Ensures oversight of data and information in study specific systems eg. EDC, CTMS, eTMF is current and accurate. </li>
<li> May lead a cooperative effort on a project team or contribute as a subject matter expert on key projects and initiatives to identify and implement process improvements and standards. </li>
<li> Other supportive duties as assigned to achieve operational objectives. </li>
</ul>
COMMUNICATION &amp; INTERPERSONAL SKILLS 
<ul>
<li> Must have high quality written and oral communication skills, with the ability to convey overall objectives and maintain open lines of communication between the internal stakeholders and service providers. </li>
<li> Must have negotiation and project management skills with the ability to coordinate across projects/program/timelines.</li>
<li> Ability to integrate into and collaborate effectively with a remote cross-functional team environment (US, APAC, EU) with a positive attitude. </li>
<li> Ability to prioritize and handle multiple activities daily yet flexible and responsive to frequently shifting priorities. </li>
<li> Models our core values: Passion, Integrity, Innovation, and Patient Focus </li>
</ul>
CORE COMPETENCIES, KNOWLEDGE, AND SKILL REQUIREMENTS 
<ul>
<li> PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint) </li>
<li> In-depth understanding of FDA and EU regulations, ICH Guidelines and GCP requirements governing the conduct of clinical trials. </li>
<li> 3 days a week on-site in the South San Francisco office (flexible) </li>
</ul>
REQUIREMENTS 
Education 
<ul>
<li> Bachelor’s degree or equivalent (scientific or healthcare discipline preferred) </li>
</ul>
 Experience 
<ul>
<li> 7+ years of experience in a biotech or pharmaceutical company, leading cross-functional clinical activities with increasing responsibility and scope </li>
<li> Minimum of 3+ years study management experience in clinical and drug development, including management of studies outsourced to CROs. </li>
<li> Experience in selecting, managing, and overseeing sites, CROs, specialty labs and other service providers in global, multinational studies or programs. </li>
<li> Experience in supporting SOP development and implementation is desired. </li>
<li> Experience working on global teams is desired, Asia-Pacific and EU highly preferred.</li>
</ul>
TRAVEL - Up to 30%

The target salary range for this full-time role is $155,000 - 190,000 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.

Sr. Clinical Trial Manager

<h3>Job Description</h3>
Company Overview
Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer and Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&amp;D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom.
Position Summary
Reporting to the Associate Director of Clinical Operations, this individual will have primary responsibility for trial management within in vivo, regenerative medicine, or oncology indications. The successful hire will adhere to best practices ensuring rigor and high-quality execution of clinical trials from FIH through commercial marketing authorization. This person will manage cross functional relationships with internal and external stakeholders and be the clinical operations representative to the respective program clinical sub-team. This individual will be hands on with trial sites fostering relationship development with KOLs. This is a high visibility position with great impact potential.
Responsibilities
<ul>
<li>Responsible for managing CROs/vendors for assigned trials ensuring adherence to defined scope of work and budget</li>
<li>Identify issues and implement solutions to ensure timelines are maintained</li>
<li>Develop and maintain tracking tools for clinical trials including, but not limited to, site start-up status, enrollment, study and monitoring visits, sample tracking, data entry and review and action items</li>
<li>Assist with the drafting of protocols, informed consent forms, study operations guidelines and other study plans</li>
<li>Oversee vendors and actively participate in all UATs for vendor systems, including IRT, EDC, Central Labs, etc</li>
<li>Develop trial specific training tools for site utilization</li>
<li>Oversee maintenance of the eTMF</li>
<li>Work with CRISPR financial management to reconcile monthly actual and forecast budgets</li>
<li>Monitor and/or co-monitor clinical trial sites, if needed</li>
<li>Plan, coordinate and participate as needed in advisory boards, investigator meetings and CRA trainings</li>
<li>Work collaboratively with supply chain to ensure seamless delivery of drug product to clinical sites</li>
<li>Develop project-specific procedures and processes</li>
<li>Develop and maintain study storyboards</li>
<li>Recommend and follow up on corrective actions to ensure quick resolution of deviations or quality issues</li>
<li>The candidate must maintain a high standard of professionalism, and confidentiality in this role and must be able to problem solve, communicate effectively, and trouble-shoot creatively</li>
</ul>
Minimum Qualifications
<ul>
<li>BS/BA/BSN – health/science and 6+ years of professional experience working in a clinical research environment (clinical site, Clinical Research Organization, or biotech/pharma company), including 2+ years of Clinical Trial Management experience.</li>
<li>Excellent communication, writing and presentation skills</li>
<li>Demonstrated ability to work independently as well as in a team environment and seek resources as necessary.</li>
<li>Ability to assess complex issues and propose viable solutions</li>
<li>Demonstrated ability to lead and organize team meetings</li>
<li>Ability to foster effective relationships with vendors, investigators and colleagues</li>
<li>Ability to contribute technical expertise to the various aspects of the clinical trial process.</li>
<li>Knowledge of industry standards as applied to ICH guidelines, GCPs and the CFR</li>
<li>Proficiency in study monitoring activities</li>
<li>Knowledge of the infrastructure and operational characteristics of CROs and centralized services.</li>
<li>Demonstrated effective time management skills</li>
<li>Must be willing to travel domestically and internationally up to 15-20%</li>
</ul>
Preferred Qualifications
<ul>
<li>MS or advanced degree</li>
<li>5+ years in a Clinical Operations Management role</li>
<li>Global trial management experience</li>
<li>Prior Clinical Monitoring and/or CRO experience</li>
<li>Knowledge of First in Human trial management</li>
<li>Experience with oncology and/or transplant</li>
<li>Experience with cellular therapy trial management</li>
<li>Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands</li>
<li>Communication and Teamwork – The ability to effectively express ideas in written and oral context. The ability to work co-operatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals.</li>
<li>Effective Planning - Embedding discipline and thoroughness in our approaches.</li>
<li>Perseverance – Pursues tasks with energy, drive and initiative, even in the face of adversity.</li>
<li>Problem Solving – The ability to understand a situation, task or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.</li>
<li>Relationship Building – Builds and maintains productive working relationships across a diverse spectrum of people.</li>
</ul>
Competencies
<ul>
<li>Collaborative – Openness, One Team</li>
<li>Undaunted – Fearless, Can-do attitude</li>
<li>Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.</li>
<li>Entrepreneurial Spirit – Proactive. Ownership mindset.</li>
</ul>
CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
To view our Privacy Statement, please click the following link: <a href="http://www.crisprtx.com/about-us/privacy-policy" target="_blank">http://www.crisprtx.com/about-us/privacy-policy</a>
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G6IiwSO9mm

<h3>Job Description</h3>
Salary: $72,000 - $88,000
We are looking for a Clinical Trial Manager II to join our team!
Are you well organized and adaptable to unexpected changes? Someone who is able to see the bigger picture, without losing sight of the day-to-day tasks? If the answer is yes, keep reading!
Clinical Trial Manager II serves as the primary point of contact for clinical trials site operations. 

Remote candidates are welcome to apply.
In this position you will:
<ul>
<li> Serve as the secondary contact to address site questions when the site Clinical Research Associate (CRA) or Research Assistant (RA) is unavailable. </li>
<li> Ensure CPC SOPs, Good Clinical Practice guidelines and applicable federal, state and local regulations are being followed.</li>
<li> Review monitoring visit reports and follow-up letters for Site Endpoint Evaluation Visits, Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits and Addendums and work with CRAs to clarify issues and finalize reports and follow-up letters.</li>
<li> Review site specific Informed Consent Forms (ICFs) to address site specific changes and escalate to internal or external parties for approval, as needed.</li>
<li> Provide the Project Manager with metrics and updates on sites including but not limited to: study related site enrollment, site activations, protocol deviations, monitoring reports and follow-up letters status.</li>
<li> Assure proper maintenance of site required records for monitoring activities and required regulatory documents per CPC requirements. </li>
<li> Create and/or review study-specific monitoring visit reports and, follow-up letter templates, and project specific site materials including Monitoring Plans, ICF templates, Study Procedure Manual, source document and site newsletter.</li>
<li> Work with CRAs, RAs and new Clinical Trial Managers on overall site management including identification, escalation and resolution of site related compliance issues. </li>
<li> Oversee Investigational Product (IP) release and once IP release has occurred, work with the RAs to collect all new or expiring Investigator regulatory documents.</li>
<li> Oversee and approve site activations and IP release. </li>
<li> Participate in project-related and other departmental/CPC meetings as required.</li>
<li> Oversee the selection of qualified sites and Investigators for participation in research protocols.</li>
<li> Work with sites to negotiate the study site budget. Oversee tracking, request and work with the Finance department on processing study site payments.</li>
<li> Oversee project specific training of site staff.</li>
<li> Train new Clinical Trial Managers on reviewing and processing monitoring visit reports and follow-up letters, completing metrics and updates, tracking site specific documents, and creating project specific documents.</li>
<li> Attend project team meetings as necessary and provide CRAs with updated study information to support their monitoring and SEEV activities.</li>
<li> Work closely with other team members to ensure timely resolution of site issues.</li>
<li> Conduct drug tracking and disposition as required by project. </li>
<li> Overseeing remote monitoring. </li>
<li> Ensure Clinical Trial Management System (CTMS) remains up to date with all site trial activities including but not limited to site communications, document status, monitoring visits, protocol deviations. </li>
<li> Conduct site monitoring visits or co-monitoring visits, as needed. </li>
</ul>
Here’s what you will need to bring to the table:

<ul>
<li> Nursing or bachelor’s degree preferred.</li>
<li> A minimum of 3 years of experience in clinical research setting required.</li>
<li> Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials. </li>
<li> Thorough understanding of the drug development process.</li>
<li> Proficiency in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint).</li>
<li> Experience with electronic data capture systems.</li>
<li> Excellent interpersonal communication skills, organizational skills and a great attention to detail. Ability to organize and instruct staff, while promoting group effort and achievement.</li>
<li> Ability to carry out multiple tasks simultaneously.</li>
<li> Ability to complete tasks in an accurate and timely manner.</li>
<li> Ability to manage conflicts and resolve problems effectively.</li>
<li> Ability to discern priorities with minimal direction to accomplish day-to-day tasks.</li>
<li> Willingness to travel up to 25% of the time. </li>
</ul>
Note: Viable applicants will be required to pass a background and education verification check.
Targeted Compensation: $72,000 - $88,000 annually

Deadline to Apply: May 1, 2024

About CPC:

CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more. 
CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.
CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. <a href="http://www.cpccommunityhealth.org/" target="_blank">http://www.cpccommunityhealth.org/</a>
CPC offers:

<ul>
<li> Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)</li>
<li> Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)</li>
<li> 11 paid holidays</li>
<li>15 - 25 vacation days based on years of service</li>
<li>Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) </li>
<li> In-suite exercise and relaxation room</li>
<li> Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)</li>
<li> Flexible and remote work schedules</li>
</ul>
An Equal Opportunity Employer

CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.
Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at <a href="mailto:careers@cpcmed.org" target="_blank">careers@cpcmed.org</a>.
remote work

Clinical Trial Manager II

<h3>Job Description</h3>
ORGANIZATION
RemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein engineering/design technologies, and extensive knowledge in clinical development, our vision is to uncover the novel therapeutic targets and develop the best-in-class and first-in-class biotherapeutics for the patients with significant unmet medical needs. RemeGen Bioscience is a wholly owned subsidiary of RemeGen Co., Ltd a global pharmaceutic company specialized in autoimmune, oncology and ophthalmic diseases. 
POSITION SUMMARY
As a Clinical Trial Manager/Sr. Manager, you will be responsible for overseeing and managing clinical studies, ensuring the successful execution of trials, and maintaining compliance with regulatory guidelines. Your key responsibilities will include preparing and managing clinical studies, managing third party vendors and Contract Research Organizations (CROs), contributing to protocol development, monitoring data integrity and patient safety, and ensuring adherence to study timelines and budgets. This is a remote role open to candidates in Massachusetts, Pennsylvania, South Carolina, and Texas.
KEY RESPONSIBILITIES
<ul>
<li>Clinical Study Management: Take a lead role in the planning, implementation, and management of clinical studies from Phase 1 to Phase 3. Ensure that studies are conducted in accordance with applicable regulations, guidelines, and protocols. Coordinate study activities, including stie selection, study initiation, patient recruitment, data collection, and study close-out.</li>
<li>Vendor Management: Oversee and manage relationships with CROs and other third-party vendors involved in the clinical trial planning and execution. Participate in vendor selection for services such as bioanalysis, data management, and other study-specific needs.</li>
<li>Protocol Development: Contribute to the development of clinical study protocols, collaborating with cross-functional teams to ensure that protocols are scientifically sound, feasible, and compliant with regulatory requirements. Provide input on study design, objectives, endpoints, and patient eligibility criteria. </li>
<li>Clinical Document Review and Writing: Assist in the review and writing of clinical documents, including but not limited to study protocols, investigator brochures, informed consent forms, case report forms, and clinical study reports. Ensure that documents are accurate, complete, and adhere to regulatory guidelines.</li>
<li>Data Monitoring: Monitor study data remotely, on-site, or through approved modes, with a focus on data integrity and patient safety. Ensure compliance with specific country regulations governing clinical trials. Identify and address data discrepancies and protocol deviations in a timely manner.</li>
<li>Site Staff Training: Provide training to site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion. Ensure that site staff are knowledgeable and adhere to good clinical practice (GCP) guidelines throughout the study.</li>
<li>Study Monitoring and Visits: Play day-to-day activities for study monitoring and set priorities for site visits. Lead the team in conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites. Maintain regular contact with investigator sites between visits.</li>
<li>Timeline and Budget Adherence: Ensure adherence to study timelines and budgets by closely monitoring project milestones, resource allocation, and expenses. Identify and address any delays or budgetary concerns promptly and implement appropriate corrective actions.  </li>
</ul>
REQUIREMENTS
Education:
<ul>
<li>Bachelor of Science or equivalent degree, required.</li>
<li>Advanced degree preferred.</li>
</ul>
Experience:
<ul>
<li>5+ years of experience of global clinical trial operation in biopharmaceutical companies.</li>
<li>Experience in global phase 1-3 clinical trials in autoimmune diseases, strongly preferred.</li>
<li>Comprehensive knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP.</li>
<li>Successful track record in study planning, country/site selection and activation, patient recruitment and retention, data cleaning, and data base lock.</li>
</ul>
Skills:
<ul>
<li>Strong project management skills with the ability to prioritize tasks and meet deadlines.</li>
<li>Detail-oriented with a focus on data integrity and patient safety.</li>
<li>Proficiency in using clinical trial management systems and electronic data capture systems.</li>
<li>Excellent written and verbal communication skills.</li>
<li>Ability to work cross-functionally in a fast-paced, collaborative environment.</li>
<li>Strong attention to detail and problem-solving skills.</li>
</ul>
BENEFITS
Benefits:
<ul>
<li>401(k) and matching program</li>
<li>Medical, Vision, and Dental Insurance</li>
<li>Flexible Spending Account</li>
<li>Short- and long-term disability</li>
<li>Life insurance</li>
<li>Employee Assistance Program</li>
<li>Employee discounts</li>
<li>Paid time off/vacation/sick time</li>
<li>Professional development assistance</li>
<li>Referral program</li>
</ul>
RemeGen Biosciences is an Equal Opportunity Employer. RemeGen Biosciences’ success depends heavily on the effective utilization of qualified people, regardless of their race, ancestry, religion, color, sex, age, national origin, sexual orientation, gender identity and/or expression, disability, veteran’s status, or any other characteristic protected by the law. As a company, we adhere to and promote equal employment opportunity (EEO) for all.
Must be able to work legally in the United States without sponsorship from employer. 
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Clinical Trial Manager, Autoimmune

<h3>Job Description</h3>
Salary: 
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients.
We are seeking an experienced Sr. Clinical Trial Manager responsible for the execution of clinical studies to required quality standards, ensuring the integrity of the clinical data on schedule and within budget for phase I-IV clinical trials by overseeing and managing vendors, junior staff, and contractors with a 1-2 year horizon.
Key Responsibilities

Manage all day-to-day operations of
<ul>
<li> Overall operational execution of a large Phase 3 global clinical study from initial study synopsis through final project deliverables (study set-up, enrollment, conduct, database lock, final TLFs, CSR, etc.).</li>
<li> Manage aspects of a clinical trial from start-up through completion, including writing protocols, informed consent documents, and contributing to clinical sections of Investigator Brochures.</li>
<li> Responsible for site and vendor feasibility, capabilities assessment, selection, management, and oversight.</li>
<li> Manage the implementation, on-time execution, and conduct of clinical studies, including contributing and tracking the development of budget items, milestones, and timelines, in addition to contributing to the scope and management of resources (including vendor selection). All leading to overall quality, safety, and compliance throughout the duration of the clinical studies and program.</li>
<li> Coordination of cross-functional study team members (bio stats, clinical pharmacology, data management, medical monitors) to ensure initiation and execution of the clinical study deliverables within the approved budget and timelines.</li>
<li> Risk management and mitigation including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished on time.</li>
<li> Provide recommendations in vendor identification/qualification/selection and oversight with a proven track record of successful execution and study completion activities.</li>
<li> Contribute to or lead the systems set-up/management including EDC, IWRS, Central Laboratories, and specialty services (ePRO, eDiary, etc.).</li>
<li> Understanding of how to review, oversee and deliver the trial endgame, which is the data and statistical analyses by critically assessing data to detect trends and outliers to efficiently direct resources and attention to correct problems early.</li>
<li> Ensure data integrity through oversight of routine data reviews, query and resolution, consistency checks both internally and for independent data monitoring committees.</li>
<li> Effectively tracks and communicate (verbally and in writing) program/study progress to Portfolio/Program Directors and Senior Management  with ability to create and update detailed dashboards and trackers.</li>
<li> Responsible for timely submission of documents to TMF.</li>
<li> Awareness of disease/ treatment landscape, changing regulations and guidance with ability to assess the impact on clinical projects and make modifications as necessary.</li>
<li> Ability to creatively approach challenges and problem resolution to optimize the conduct of clinical trials.
</li>
</ul>
Qualifications &amp; Requirements 

<ul>
<li> Demonstrated experience in core and technical aspects of initiating and managing phase 1-4 clinical trials.</li>
<li> Demonstrated experience in management of sites, CROs and vendor selection.</li>
<li> Demonstrated willingness to be hands-on and perform tasks within tight turnaround time.</li>
<li> Possessing excellent interpersonal and communication skills, with developing leadership attributes.</li>
<li> Success working in a matrixed environment.</li>
<li> Demonstrated experience in the application of US and Global Regulations and Guidance (SOPs, ICH-GCP, FDA-CFR, ethical standards).</li>
<li> Experience in data collection, monitoring, cleaning, and analysis throughout clinical development (Phase 1-4).</li>
<li> Proficiency in Microsoft Office (Word, Excel, Outlook, and Project), electronic TMF, and electronic clinical technologies.</li>
<li> Able to multi-task in a fast-paced environment.</li>
<li> Able to build strong cooperative relationships with coworkers.</li>
<li> Listens, seeks common ground and establishes credibility.</li>
<li> Author complex documentation with minimal supervision.</li>
<li> Possess a high degree of attention to detail.</li>
<li> Proactive and accountable.</li>
<li> Previous employment at a pharmaceutical, biotech company or CRO preferred.</li>
</ul>
Preferred Education

B.A. or advanced degree in biological science or life sciences discipline.
Certifications a plus ex. Project Management Professional, Clinical Trials Design and Management, etc.

Preferred Experience

At least 6 years of relevant experience in clinical operations. Experience in late phase of development required. Comfortable with travel and able to travel up to 25% of the time as needed.

Preferred Computer Skills

Thorough working knowledge of personal computer systems and desktop office applications.
Alumis Values

<ul>
<li>Elevate</li>
<li>Challenge</li>
<li>Nurture</li>
</ul>
This position is located in South San Francisco, CA. Team members are required in office 3 days per week. At this time we are not considering remote applicants. 
The salary range for this position is $ 178,000 USD to $195,000 USD annually. This salary range is an estimate, and the actual salary may very based on the Company’s compensation practices.

Alumis Inc. is an equal opportunity employer.

Senior Clinical Trial Manager

<h3>Job Description</h3>
WHY VITALIEF?
Vitalief is a pioneering consultancy addressing the healthcare human capital epidemic.  Join us and help clients adapt to evolving requirements in the research and clinical trial industry with cutting-edge solutions.  
Reasons to Work for Vitalief:
<ul>
<li>Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees.</li>
<li>We give everyone a seat at the table – we encourage innovation.</li>
<li>We’re committed to our employees – you are encouraged and mentored by the talented Vitalief team to achieve full potential.</li>
<li>“Life/Work” balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually.</li>
<li>Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from.</li>
</ul>
Salary Range:  $75,000 to $90,000 annually
Work Location:  Work is 5 days per week on-site in New Brunswick, NJ.  Ability to work one day remote per week after acclimated.
Responsibilities:
<ul>
<li>Under the direct supervision of the Nurse Manager of Clinical Research Center, performs patient recruiting/pre-screening/consenting/retention; activation; regulatory compliance, data management. and other clinical trial activities for solid tumor, high enrollment, adult population Oncology related trials. </li>
<li>Serves as a liaison between the organization, investigators, members of the research team (i.e., physicians, nurses, hospital, and laboratory staff), and the research sponsors – to ensure that services are coordinated and delivered to patients in a timely manner.</li>
<li>Maintains research record (e.g., patient consent, eligibility, Case Report Forms (CRF), registration confirmation, corresponding source documents, etc.) for all patients enrolled in Oncology trials.</li>
<li>Participates in site preparation for trials including protocol feasibility, preliminary study budget, startup meeting preparation, training staff, and preparation of IRB applications and preparation of regulatory documents, study documents and forms.</li>
<li>Conducts trial visits by informing patients and coordinating procedures per protocol.</li>
<li>Assesses and triages study patients appropriately for serious/unexpected adverse events (SAE), reports and records adverse events according to all applicable regulation and study protocol. </li>
<li>Assists patients in understanding their diagnosis, treatment options, and the resources available including educating eligible patients about appropriate clinical research studies and technologies.</li>
</ul>
Required Skills:
<ul>
<li>2 or more years of experience in clinical research as a Clinical Research Coordinator, with experience in patient recruiting/pre-screening/consenting/retention; activation; regulatory compliance, data management, and ensuring Serious Adverse Events (SAEs) are completed and reported within reporting deadlines outlined in the protocol. </li>
<li>Bachelor’s Degree required.</li>
<li>Oncology clinical research experience is required. </li>
<li>Any experience working with solid tumors is a big plus. </li>
<li>Compassionate personality and ability to interact with patients in a clear and confident manner.</li>
<li>Ability to work on several trials concurrently – can demonstrate versatility, “can do” attitude, and possess strong organizational, time management and prioritization skills.</li>
</ul>
PHYSICAL DEMANDS: Standing, sitting for long periods of time working on a computer, visual perception, walking, talking and hearing. Lifting up to 25lbs.
IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that requires all on-site resources such as prospective Vitalief consultants to provide proof that they are fully vaccinated for Covid-19; inoculated annually for Influenza; and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.
#LI-DNI
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Clinical Trial Specialist

<h3>Job Description</h3>
Salary: 
Overview
The Clinical Trial Manager in the Research Alliances team will oversee the planning, execution, management, and reporting of clinical projects supporting Iovance commercial activities, including expanded access programs (intermediate and single-patient) and Phase 4 post marketing pharmacovigilance studies.  In addition, the Clinical Trial Manager will support a growing portfolio of Investigator Sponsored collaborations and other non-clinical collaborative research initiatives involving lifileucel and Proleukin. This position works very closely with external vendors, HCPs, as well as multiple Iovance teams: Commercial, Medical Affairs, Regulatory, Safety, Clinical, Biometrics, Quality, Legal, Quality, Supply Chain &amp; Logistics and Manufacturing.  
The ideal candidate will have clinical operations experience within the pharma/biotech arena, be self-motivated, and able to work in a dynamic, agile, transitioning organization. 
Essential Functions and Responsibilities
<ul>
<li>Performs day to day activities for the timely activation, execution, and management of Expanded Access Programs (EAPs) that support commercial launch activities at authorized treatment centers  </li>
<li>Performs day to day activities for the timely activation, execution, and management of Post Marketing Safety Surveillance study </li>
<li>Performs day to day activities for the timely activation, execution, and management of ISTs/non-clinical research projects </li>
<li>Ensure Sunshine Act reporting data for lifileucel and Proleukin products across Research Alliances programs are collected </li>
<li>Works closely with Legal to initiates CDAs, clinical trial and service agreements, amendments and change orders for EAPs, Phase 4, Investigator-Sponsored and non-clinical collaborations.</li>
<li>Manages external contract research organizations involved with EAPs and Phase 4 who will have responsibility for site interaction, site monitoring, patient schedule management, data collection/management, central IRB interaction, and clinical site contracts.</li>
<li>Oversee drug supplies, co-therapies, and lab supplies for clinical and non-clinical collaboration studies and EAPs.</li>
<li>Reports to Iovance teams on study status, activity and site/vendor performance. Track and communicate study progress using dashboards and trackers. </li>
<li>Ensure that Investigative sites submit monthly enrollment logs, safety listings, database transfers and quarterly reports or as required in the study agreements. </li>
<li>Responsible for the writing and updating workflows, manuals, consent forms, and technical documents to support EAPs, Phase 4, ISTs/collaborations and non-clinical studies. </li>
<li>Organizes and document decisions of routine meetings with internal teams, CROs and Investigator/research teams. </li>
<li>Collect and maintain essential regulatory documents.</li>
<li>Contribute and lead process improvements by updating or developing SOPs and Work Instructions.  </li>
<li>Perform all necessary tasks, regardless of level, to facilitate success at driving a project/program to completion. </li>
<li>Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.</li>
</ul>
<ul>
<li>Perform other miscellaneous duties as assigned.</li>
</ul>

Travel - 20% of the time.
Required Education, Skills, and Knowledge
<ul>
<li>Bachelor’s degree in health or science-related area with 5+ years of clinical operations experience in the pharmaceutical or biotech area. </li>
<li>Capable of independently initiating and managing EAPs and Phase 1-4 clinical trials </li>
<li>Track record of building positive investigative site relationships and management of investigative sites. </li>
<li>Possessing excellent interpersonal and communication skills (written and oral). </li>
<li>Confident, flexible and independent personality that thrives in a dynamic, fast-paced result-oriented environment. </li>
<li>Knowledge of US and Global Regulations and Guidance (ICH-GCP, FDA-CFR) </li>
<li>Experience in data collection, review and monitoring Phase 1-4 clinical studies </li>
<li>Demonstrated experience leading phase 1-4 clinical trials and supporting ISTs.</li>
</ul>
<ul>
<li> Demonstrated success in managing clinical studies within timeline and budget. </li>
<li> Strong interpersonal and communication (verbal and written) with the ability to build strong relationships with peers and partners within and across functional teams to engage in high performance.</li>
<li> In-depth knowledge of Microsoft Office, including MS Word, MS Excel, MS PowerPoint, and MS Outlook</li>
<li> Previous experience with EDC systems (eClinical, Medidata RAVE, InForm), and electronic Trial Master File systems </li>
<li> Requires working knowledge of Good Clinical Practices, Food and Drug Administration regulatory reporting requirements, and the regulations and laws governing the pharmaceutical industry (e.g., compliance, Sunshine Act)</li>
</ul>
Preferred Education, Skills, and Knowledge

<ul>
<li>Oncology/immunotherapy experience</li>
<li> Phase 4, Expanded Access Program experience</li>
</ul>
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. 
Physical Demands and Activities Required 
<ul>
<li> Must be able to remain in a stationary position standing or sitting for prolonged periods of time. </li>
<li> Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects. </li>
<li> Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading. </li>
<li> This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.</li>
<li> Must be able to communicate with others to exchange information.</li>
</ul>

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment 

This job operates in a professional or remote office environment and requires using standard office equipment and keyboards.  
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They do not constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or change the position’s responsibilities at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please get in touch with <a href="mailto:careers@iovance.com" target="_blank">careers@iovance.com</a>.
 By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice. 

#LI-hybrid

Clinical Trial Manager, Research Alliances

<h3>Job Description</h3>
Clinical Trial Operations (CTO)
The CTO will work remotely as a member of the Clinical Trial Team in the Study Management and Conduct Group supporting the Clinical Trial Leader (CTL), Clinical Trial Manager (CTM), and Feasibility Manager (FM). The CTO is responsible for end-to-end site management activities.
In addition, may be responsible for supporting the CTL and/or CTM in leading the trial teams and is responsible for end-to-end Site Management activities.   
Requirements:
Four (4) year degree, preferably in life sciences, or an RN with relevant clinical trial experience.
Experience:
<ul>
<li>oncology: 5 years (Preferred)</li>
<li>in-house monitoring: 7 years (Preferred)</li>
</ul>
General Responsibilities
<ul>
<li>Represent clients PI with the highest ethical and professional standards with all business contacts including, but not limited to the following representatives: investigator and site staff, clinical trial team, Regulatory Affairs, Client Site Monitoring staff, other departments in Clinical Operations and clinical trial vendors, if required.</li>
<li>Maintain expertise of currently assigned Client SOPs, Client WIs and where applicable; departmental practices, and systems.  </li>
<li>Maintain current knowledge of ICH, GCPs, and applicable FDA guidelines, US Federal Regulations pertaining to Clinical Trials and Guidance Documents and Information Sheets. PhRMA code, and industry standards for the monitoring of clinical trials at no cost to Client.</li>
<li>Provide documentation, including but not limited to invoices, time recording, schedule of monitoring visits, and schedule of time off at the direction of Client.</li>
<li>Invoices should be submitted monthly as directed by Client. The invoices may not be processed until all work products for that period have been received.</li>
</ul>
CTO Duties and Responsibilities:
Under the direction of the CTL/CTM or Feasibility Manager (depending on the task/activity), the CTO will:
<ul>
<li>Serve as the first line of contact for site staff in trial-related questions pertaining to planning, conduct, and closure of assigned clinical trials and sites.</li>
<li>Coordinate and provide oversight to site start-up and conduct-related activities (e.g. contracts, Essential Documents (e.g. RegDocs), training, Informed Consent Form (ICF) updates, Investigational Medicine Product (IMP) re-supply.</li>
<li>Be responsible for site logistics including review, distribution, and tracking of site-related documents &amp; materials (e.g.  protocols, supplies).</li>
<li>Update and maintain trial-specific system/databases/tracker (e.g. IVRS, BI CTMS, Feasibility Database &amp; Site outreach metrics).</li>
<li>Adhere to project compliance according to project plans and related tools.</li>
<li>In close partnership with additional stakeholders (e.g. ISP Manager, Site Monitoring) maintain/improve quality, performance, and operational oversight for assigned sites, take appropriate actions, escalate, implement mitigation strategies, and make recommendations to the CTM and/or FM as appropriate</li>
<li>Perform monitoring trip report review according to current SOPs and guidance documents. Communicate significant issues to the CTL and CTM.</li>
<li>Serve as CAPA lead.</li>
<li>Develop trial-specific documents or communications (e.g. newsletters). Submit for review and approval to CTL and CTM.</li>
<li>Closely track site recruitment and patient retention.</li>
<li>Ensure data quality and integrity through a review of systems and trackers (e.g. BRAVE, lab portals, Clinergize).</li>
<li>In collaboration with partners ensure quality of TMF for assigned sites.</li>
<li>Review and reconcile invoices/payments with internal partner(s), as appropriate.</li>
<li>Actively participate in trial team meetings including the creation and distribution of meeting minutes.</li>
<li>Create trial-specific slide decks, training material, etc. in accordance with BI requirements.</li>
<li>Support Customer Relations Group (CRG) in answering and appropriately triaging calls from (potential) sites, as needed and/or requested to appropriate stakeholders.</li>
<li>Participate in (local/regional) Investigator Meetings, as requested.</li>
<li>Support site &amp; sponsor inspection readiness activities.</li>
<li>If US CTL is assigned, provide additional support of global/local activities as required</li>
<li>Support Investigator Site File (ISF) development according to SOP and guidance documents.  Adapt Trial/OPU documents/templates for study specific trials.</li>
<li>Perform quality control of Clinical Trial Report (CTR) Appendices, as requested.</li>
<li>Provide operational support to the assigned study Feasibility Manager with tasks to support site identification and country feasibility, i.e., tiering of potential investigator sites, vetting requests, assessing investigator qualifications, etc.</li>
</ul>
Additional Provisions for CTO Role:
Additional CTO non-trial services may be requested from time-to-time on an as-needed basis related to leveraging service knowledge and insights supporting other activities.
In addition to the CTO responsibilities and duties, they may assist in leading the trial team:
<ul>
<li>Operationalize the strategic direction given by the CTL/CTM during planning, conduct and closure of assigned trials.</li>
<li>Provide quality oversight for assigned trial.</li>
<li>Enter country-level information in BI Clinical Trial Management System (CTMS) and related systems.</li>
<li>Perform user acceptance testing.</li>
<li>Facilitate local trial team meetings.</li>
<li>Update trial budget, systems, project plans and tracker.</li>
<li>Serve as single point of contact for all CTOs assigned to the trial including the coordination and harmonization of activities, answering trial related questions, etc.</li>
<li>Provide reports to CTL/CTM on OPU contribution status, local issues, budget etc.</li>
<li>Partner with the CTL/CTM in the development of a local trial implementation strategy (incl. site engagement/selection/start-up strategy).</li>
<li>Work with local colleagues to ensure start-up is achieved according to local timelines/goals.</li>
<li>Support the CTL/CTM in study sites review and selection.</li>
<li>Support CTL/CTM in the preparation and conduct (may include delivery of presentations and trainings) in (local/regional) Investigator Meetings if required.</li>
<li>Provide updates on key trial deliverables; take appropriate actions and make recommendations to the CTM (e.g. site initiation, patient recruitment, data cleaning, DBL).</li>
<li>Follow up on audit/inspection findings and actively support implementation of CAPA.</li>
<li>Support accurate local budget and collaborate with CTM to ensure alignment with controlling.</li>
<li>In collaboration with partners, ensure quality of country level TMF.</li>
<li>Supports the CTL/CTM in ensuring quality oversight and data integrity of the trial at the country level.</li>
<li>Support site &amp; sponsor inspection readiness preparation, represent the trial (Trial/OPU level) during inspections if requested and as appropriate.</li>
<li>In close partnership with the Recruitment and Retention group, CTL and CTM, implement recruitment and retention strategies.</li>
<li>Assist with vendor oversight (e.g. lab, ancillary supplies, and pharmacy cards).</li>
<li>Coordinate close-out activities (collection of essential documents, etc.).</li>
</ul>
Requirements:
Four (4) year degree, preferably in life sciences, or an RN with relevant clinical trial experience.
Experience:
<ul>
<li>oncology: 5 years (Preferred)</li>
<li>in-house monitoring: 7 years (Preferred)</li>
</ul>
Desired Experience, Skills and Abilities:
<ul>
<li>Excellent communication skills (written and oral)</li>
<li>Be a highly motivated individual with the ability to think critically, that is detail-oriented, can multi-task and understand the clinical trial process, meet deadlines and keep a trial /site on track along with any other qualifications provided by Sponsor.</li>
<li>Proficiency in computer skills, with direct working experience in multiple electronic platforms such as but not limited to: CTMS  SharePoint, Clinical Trial portals, Central IRB portals, eSurvey platforms, Time reporting portals, eLearning portals, Access Databases, Microsoft Excel, Microsoft Teams, Adobe Acrobat Professional and scanning software etc.</li>
<li>Maintain expertise of currently assigned Sponsor SOPs, Working Instructions (WI), and where applicable, departmental practices.</li>
<li>Maintain current knowledge of ICH, GCPs, applicable FDA guidelines, US Federal Regulations pertaining to Clinical Trials and Guidance Documents and Information Sheets, PhRMA code, and industry standards for the monitoring of clinical trials at no cost to Sponsor.</li>
<li>Represent Sponsor with the highest ethical and professional standards with all business contacts including, but not limited to the following representatives: investigator and site staff, clinical trial team, Regulatory Affairs, Site Monitoring staff, other departments within Clinical Operations, and if required clinical trial vendors.</li>
</ul>
Job Type: Full-time
Salary: $50.00 - $54.00 per hour
Schedule:
<ul>
<li>8-hour shift</li>
<li>Day shift</li>
<li>Monday to Friday</li>
</ul>
Work Location: Remote
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64 Remote Clinical Trial Manager Jobs