<h3>Job Description</h3>
Salary: $150,000 - $173,000
Overview

We are seeking an experienced and organized Trial Master File (TMF) Manager to oversee and lead the development and management of Iovance TMF. The TMF Senior Manager serves a key role, working across the business for the execution of TMF Operations processes and strategy. 
The TMF senior manager will provide tactical support and strategic guidance on TMF processes, filing conventions, index creation, maintenance, and other TMF related matters. TMF manager to ensure Iovance’s compliance with applicable regulatory requirements. As the TMF Manager, you will play a pivotal role in creating and maintaining consistency across studies and programs to ensure essential trial documents are appropriately collected, indexed, stored and accessible, while adhering to regulatory and company standards. As required, you will also roll-up your sleeves to drive and conduct TMF remediation efforts, inspection readiness activities, audits, and inspections. 
Essential Functions and Responsibilities
<ul>
<li> Lead the development, implementation, and evolution of Iovance cross-functional TMF SOPs, procedures, training, CRO partnering agreements, and best practices.</li>
<li> Support TMF systems implementation and consistent organizational use. This may involve hands-on participation in the configuration and maintenance of the TMF systems and development of TMF Management plan(s).</li>
<li> Ensure TMF project documentation is maintained to the highest level of quality, accuracy, completeness, and compliance with regulations.</li>
<li> Implement/Maintain TMF quality control processes aligned to GCP, company standards, and regulatory requirements.</li>
<li> Identify, gather, empower and oversee a team of internal/external SMEs responsible for the collection, tracking, and filing of trial-related documents in the TMF.</li>
<li> Lead and/or support TMF creation, maintenance, closure, as well as TMF transfer, migration, and integration activities per company and/or CRO SOPs and standards.</li>
<li> Drive and oversee clinical trial teams and CRO partners in timely filing of documents throughout the trial lifecycle.</li>
<li> Ensure accuracy, completeness, and quality of TMF content by driving, overseeing, and facilitating regular reviews and audits.</li>
<li> Provide process/planning and tactical support for TMF-related remediation as needed.</li>
<li> Lead team in development of TMF training processes and providing guidance/training to team members and stakeholders on TMF expectations, tools, procedures and compliance requirements. </li>
<li> Act as the primary point of contact for TMF-related queries, both internally and externally, and liaise with vendors, if applicable.</li>
<li> Serve as the SME for TMF during Inspections and audits; collaborate with inspection readiness teams and regulatory authorities on TMF-related inquiries and inspections.</li>
<li> Drive and lead the development of metrics to assess the completeness and quality of the TMF and effectively communicate status updates to the study team and department management. Work with external partners and study team to address gaps, issues and mitigate risks.</li>
<li> Lead meetings to escalate trends, issues, and establish standards, while problem-solving and seeking appropriate endorsement across study teams/functions. Communicate ideas, solutions, standards.</li>
<li> Stay updated with industry trends and evolving regulatory requirements related to TMF management, providing recommendations for process enhancements.</li>
<li> Lead projects in support of study or portfolio TMF objectives and attend standing cross functional meetings.</li>
<li> May manage or mentor staff members.</li>
<li> Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.</li>
</ul>
<ul>
<li>Perform miscellaneous duties as assigned.</li>
</ul>

Travel
<ul>
<li> May be required to travel for team meetings and other events as needed.</li>
</ul>

Required Education, Skills, and Knowledge

<ul>
<li> Bachelor's degree in a related field (Life Sciences, Healthcare, or similar).</li>
<li> Proven experience in clinical trial management</li>
<li> 9+ years of relevant industry experience</li>
<li>Required 5 years of Trial Master File experience</li>
<li> Strong knowledge of regulatory guidelines (e.g., ICH-GCP, FDA, EMA) pertaining to TMF.</li>
<li> Experience with electronic document management systems (eTMF) and related software.</li>
<li> Proven ability to lead and drive collaboration in a fast-paced, cross-functional team environment.</li>
<li> Excellent relationship-building, organizational, leadership, and communication skills.</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 operating 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 are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position 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 contact <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-onsite

Senior Manager, Trial Master File

<h3>Job Description</h3>
 At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a Clinical Trial Leader (CTL) to join our A-team (hybrid*/remote). As a CTL at Allucent, you are responsible for providing leadership, management and oversight to the Clinical Research Associates (CRAs) and other clinical functional groups, in their day-to-day clinical trial activities on a global, multi-country, or regional basis. The CTL is responsible for coordinating and managing the planning, implementation, tracking, and ensuring the clinical deliverables as per the trial contract, budget, timelines and with quality.
In this role your key tasks will include:
<ul>
<li>Coordinating and managing CRA activities across all geographies, liaising with sponsor and Project Manager and other functional leads to ensure clinical monitoring deliverables (timeline, budget, quality, productivity) are met, including: Managing the trial start up and site activation in collaboration with PM, Global Regulatory Lead and, if applicable, Global Site Activation Manager (GSAM). </li>
<li>Oversight of critical documentation collection, maintenance and filing. </li>
<li>Develop the Monitoring Plan and site monitoring templates and tools as well as providing input into Trial plans &amp; tools. </li>
<li>Review trial-specific documents upon request as well as develops or reviews subject-facing materials. (if necessary)</li>
<li>Customizes the annotated Site Visit Reports according to trial specific requirements. </li>
<li>Selection of investigators and sites; SEV report review and approval. </li>
<li>Site initiation management; SIV report review and approval </li>
<li>Monitoring Visit Report (MVR) review, management, resolution and escalation. </li>
<li>Where applicable, works with PM and / or patient recruitment manager to support the project recruitment timelines and (site) recruitment plan as well guiding the CRA team </li>
<li>Manages successful trial close-out, identifies critical activities to make timely and efficient close-out. </li>
<li>Responsible for timelines, budget and quality of Clinical Monitoring team deliverables, identification of risks and issues and escalation to PM, Line Manager, and GCO management . </li>
<li>Provides information and input about planned activities and status to PM and attends Project Review Meetings if/when needed. </li>
<li>Conducts project co-monitoring (if required) &amp; if needed temporarily conducts site management / monitoring in case of immediate need and lack of resources. </li>
<li>Coaches/mentors CRA team including providing performance feedback as appropriate, assisting in developing and delivering project-specific training and providing input related to Project Specific Training Matrix. </li>
<li>Prepares and chairs CRA calls and actively participates in internal trial team calls and client calls. </li>
<li>Oversees / attends CRA handovers as appropriate. </li>
<li>Serves as a site contact for protocol clarifications and subject enrolment if CRA unavailable. </li>
<li>Monitors and manages trial materials supplies ensuring Investigational Product and other trial supplies are shipped to sites.</li>
<li>Reviews data listings and query reports to identify trends and ensures proactive re-training is conducted with CRAs and site staff. </li>
<li>Oversees the process of protocol deviation and Trial non-compliance documentation, tracking and escalation. </li>
<li>Participates in the development of trial newsletters communication. </li>
<li>Requests appropriate Clinical Operations staffing, workload and resources and reports trial deliverables and resource needs. </li>
<li>Assists, where appropriate, the PM in discussions with clients on trial documentation issues or technical related documentation concerns that may arise. </li>
<li>Reviews trial systems (CTMS, CRF, IRS, central lab portal, etc.) updates on regular basis, ensures systems reports are up to date and reports generated are current and correct. </li>
<li>Oversees eTMF status. </li>
<li>Reviews trial reports and analyzes trends to recognize risks, provides input into mitigation plans and implements mitigations belonging to clinical activities </li>
<li>Contributes to optimization of trial processes to increase efficiency</li>
<li>Coordinates and provides support for trial related (site) audits &amp; inspections </li>
<li>Contributes to corrective and preventive action plans where needed and ensures their timely implementation and closure </li>
<li>Ensures project consistency within and across projects by following Allucent / relevant SOPs.</li>
<li>Assists and supports in the preparation of various training material used by Allucent (including SOPs training, as well as specific trial related). </li>
<li>Assists in the preparation and conduct of Kick-Off Meetings, Investigators’ meetings and other committees’ or Trial meetings as requested. </li>
<li>Prepares Country Level Site Facing Budgets and manages Investigator and Site Payments as applicable. </li>
<li>Supports PM in the management of trial vendors as required. </li>
<li>Project contract awareness and oversight; i.e.:</li>
<ul>
<li>Forecast and report on the site management units throughout project life cycle</li>
<li>Identify changes in scope and liaise with the Project Manager</li>
</ul>
<li>Manages client expectations related to Clinical deliverables in accordance with contracted services and Allucent QMS. </li>
<li>Provides input into proposals when required. </li>
<li>Actively participates in the preparation, attendance and presentation of bid defenses or any other presentations to potential clients</li>
<li>Complete routine administrative tasks in a timely manner (e.g. timesheets, travel expense claims, training)</li>
<li>Other responsibilities as required.</li>
</ul>
Requirements
To be successful you will possess:
<ul>
<li>Candidate must be legally authorized to work in the specified Country where job is being advertised. </li>
<li>A degree in life sciences or nursing qualification preferred, but not required </li>
<li>A minimum of 5 years clinical research experience (including a combination of SCRA + CTL/CTM, PM or Regulatory/Auditing experience) with at least 1- 2 + years CTL/CTM experience (depending on selected level CTL / Sr. CTL)</li>
<li>In-depth knowledge of ICH GCP, clinical trials and the critical elements for success in clinical trials</li>
<li>Strong therapeutic background </li>
<li>Possesses experience and knowledge in the CRO industry that will support Allucent’s management of clinical trials Skills</li>
<li>Strong written and verbal communication skills including good command of English language </li>
<li>Professional and strong client focused</li>
<li>Ability to work in a fast-paced challenging environment of a growing company </li>
<li>Administrative excellence with attention to detail and accuracy </li>
<li>Leadership and mentoring skills with ability to mentor and train other CRAs in a positive and effective manner </li>
<li>Excellent team player with team building skills</li>
<li>Strong organizational skills to be able to manage a full workload across multiple projects.</li>
<li>Demonstrates flexibility for creating solutions and process improvement </li>
<li>Analytical, financial and problem resolution skills </li>
<li>Proficiency with various computer applications such as Word, Excel, and PowerPoint, CTMS, eTMF required </li>
<li>Ability to successfully manage people/project issues </li>
<li>Mature management skills demonstrated by calm and thorough review of situations. </li>
<li>Seeks to understand all contributing factors.</li>
<li>Proposes, implements, and evaluates appropriate, creative resolutions. </li>
<li>Demonstrates the ability to define and meet project requirements </li>
</ul>
Benefits
Benefits of working at Allucent include:
<ul>
<ul>
<li>Comprehensive benefits package per location</li>
<li>Competitive salaries per location </li>
<li>Departmental Study/Training Budget for furthering professional development </li>
<li>Flexible Working hours (within reason) </li>
<li>Opportunity for remote/hybrid* working depending on location</li>
<li>Leadership and mentoring opportunities </li>
<li>Participation in our Buddy Program as a new or existing employee</li>
<li>Internal growth opportunities and career progression </li>
<li>Financially rewarding internal employee referral program </li>
<li>Access to online soft-skills and technical training via GoodHabitz and internal platforms</li>
</ul>
</ul>
Disclaimers:
*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-Hybrid #LI-DF1

Clinical Trial Leader (Cary/Wilmington, NC or Waltham, MA)

<h3>Job Description</h3>
BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Clinical Trials Associate to work for a leading Greater Los Angeles area biotechnology company. Pay Rate: $60-90/hour depending on experience This position will be REMOTE with occasional in-person meetings. All business related travel, hotel, and meals will be reimbursed. Summary:The Clinical Trials Associate with Oncology/Cell-Therapy experience will work in-house and will support the Manager, Clinical Operations in the conduct of clinical trials sponsored by the company. This individual will have responsibilities for aspects of the clinical trial to assist with study start-up, enrollment, maintenance, and close-out.
Responsibilities:
<ul>
<li>Support all operational aspects of assigned clinical trial(s), including conduct of study start-up, enrollment, study maintenance, and close-out.</li>
<li>Assist with the development, oversight, and/or completion of the clinical documents including, but not limited to:
<ul>
<li>Clinical study protocol</li>
<li>Informed consent form template (master and/or country-level) </li>
<li>Cell therapy product procedure manual and related forms</li>
<li>Clinical monitoring/management plan including report templates</li>
<li>Training slides and materials (e.g., SIV slides, protocol training materials)</li>
<li>Investigator Site File (ISF) structure and template documents</li>
<li>Others as needed study-specific documents, plans, charters, tools, trackers, etc. (including that of the CRO)</li>
</ul>
</li>
<li>Contributor and reviewer of the clinical documents below:
<ul>
<li>Clinical laboratory manual and requisition forms</li>
<li>CRFs and CRF completion guidelines</li>
<li>Interactive Response Technology (IRT) manual (e.g., IVRS, IWRS, IXRS)</li>
<li>Central imaging manual</li>
<li>Edit check / data review plan</li>
<li>Data review board charter (e.g., DSMB, SRC)</li>
<li>Safety management plan and SAE report form template</li>
</ul>
</li>
<li>Manage and/or support the Manager, Clinical Operations with oversight of the Trial Master File (TMF). Responsibilities include, but not limited to:
<ul>
<li>Filing clinical documents in the Trial Master File (TMF)</li>
<li>Assisting with the development, oversight, and/or completion of the TMF index and TMF management plan.</li>
<li>Periodically reviewing the TMF for reconciliation and QC, following up with the clinical sites, clinical trial monitors, and/or vendors to close-out TMF-related issues.</li>
</ul>
</li>
<li>Support the Manager, Clinical Operations with various meetings, may include assisting in developing meeting agendas, writing meeting minutes, and facilitating review of minutes:
<ul>
<li>Internal study team meeting</li>
<li>Other internal clinical operations meetings</li>
<li>Working group meetings</li>
<li>CRO/vendor meetings</li>
</ul>
</li>
<li>Support the Manager, Clinical Operations in the selection process of vendors and/or contractors supporting a study, including but not limited to:
<ul>
<li>CRO</li>
<li>Clinical trial monitors</li>
<li>Central lab</li>
<li>Central imaging</li>
<li>EDC system</li>
<li>IRT system</li>
</ul>
</li>
<li>Support the Manager, Clinical Operations in overseeing, managing, and tracking performance of assigned vendors selected for a clinical study which could include acting as a point of contact as delegated by the manager, facilitating review of vendor study specific documents, tracking performance indicators for vendors, creating and maintaining a vendor-specific issues log.</li>
<li>Ensures documentation of training for internal study team, vendors, third party contractors, and sites.</li>
<li>Help manage, oversee, and track performance of clinical sites selected for a clinical study, which could include acting a point of contact for the sites.</li>
<li>Facilitate sponsor review and approval of site-specific documents (e.g., site-specific ICF, patient facing materials, etc.).</li>
<li>Proactively identifies potential study issues/risks and recommends/implements solutions.</li>
<li>Participate in the development, review and implementation of departmental SOPs and processes.</li>
<li>Contribute to the selection of contractors or FTEs that join the company</li>
<li>Other duties as assigned. </li>
</ul>
Qualifications:
<ul>
<li>Minimum requirement of a BA/BS or equivalent degree, plus 1-2 years of direct experience in clinical operations supporting clinical drug development within the oncology and/or cell therapy space; OR minimum 3 years of direct experience in clinical operations supporting clinical drug development with no experience in oncology and/or cell therapy clinical studies.</li>
<li>Experience and/or knowledge of transplant patient care and apheresis collection for clinical trials strongly preferred.</li>
<li>Experience participating in the selecting and managing of CROs and other clinical trial vendors (e.g., central lab, central imaging, etc.)</li>
<li>Knowledge and understanding of ICH guidelines, GxPs for conduct of clinical trials, and FDA and EMA regulations.</li>
<li>Outstanding organizational skills with the ability to multi-task and prioritize.</li>
</ul>
Please send resumes to <a href="mailto:tiffany@biophaseinc.com" target="_blank">tiffany@biophaseinc.com</a> and visit our website at <a href="http://www.biophaseinc.com" target="_blank">www.biophaseinc.com</a> for additional job opportunities!!!

Clinical Trials Associate (REMOTE)

<h3>Job Description</h3>
Salary: $61,114 - $77,000
We are looking for an experienced Clinical Operations Manager I to join our team! 

Are you well organized, but 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!
This role is ideal for an individual who can motivate teams to do great work collaboratively in order to produce the best quality outcomes possible.
In this position you will:
<ul>
<li>Manage site identification and evaluation.</li>
<li>Develop or review essential study documents including protocols, case report forms (CRFs), source documents, project management plans, monitoring plans, reference tools, and study manuals.</li>
<li>Review site regulatory documents for compliance with CPC Standard Operating Procedures (SOPs) and applicable laws, regulations, and guidelines and to facilitate approval of investigational product release.  </li>
<li>Prepare central IRB submissions and resolve IRB issues.</li>
<li>Manage site enrollment and study subject tracking and payments.</li>
<li>Assist with the monitoring of project deliverables and project timelines.</li>
<li>Develop and distribute project documents (e.g. safety reports, lab reports, deviations reports, monitoring reports, follow-up letters, meeting minutes, newsletters, and regulatory documents)</li>
<li>Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation.</li>
<li>Provide investigational product or device tracking and disposition as required by project.</li>
<li>Develop and manage site and vendor contracts including investigational product (IP) supply, interactive voice/web response system, electronic data capture system, core labs and other applicable clinical services.  </li>
<li>Track and approve vendor payments.</li>
<li>Manage multidisciplinary project team members in relation to their role on assigned projects. Proactively identify issues and discuss resolutions with applicable department heads, project team, CPC executives and/or the sponsor. Track implementation of resolution through to completion and efficacy checks.</li>
<li>Ensure that the overall quality of project services and deliverables is maintained.</li>
<li>Provide status reports on all projects.</li>
<li>Participate in both onsite and offsite investigator meetings and training sessions.</li>
<li>Escalate budget, proposals and change orders discussions to Business Development.</li>
<li>Assist Business Development with benchmarking for budgets and development of sponsor proposals and service agreements.</li>
<li>Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact. Routinely advise management regarding the overall project status.</li>
<li>Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper.  </li>
<li>Schedule project team meetings and prepare meeting agendas and minutes as needed.</li>
<li>Perform other non-project related general administrative tasks such as filing, copying, faxing and shipping for assigned projects.  </li>
<li>Cross-train within the project team, as needed. </li>
<li>Define and monitor Endpoint and Specialty Services scope, timelines and deliverables from project initiation to closeout with assistance from study assigned Clinical Operations Manager and the Head of Endpoint and Specialty Services.</li>
<li>Provide timely feedback on the progress of project assignments; help assess project issues and propose resolutions to the CPC project lead.</li>
<li>Manage contracted deliverables for external committees (e.g. data safety monitoring boards, clinical endpoint committees), including but not limited to meeting scheduling, generation of meeting minutes and distribution of meeting materials.</li>
<li>Oversee SAE process and assure execution of safety plans.</li>
<li>Accurately track receipt, entry, upload and the processing of photos, acetate tracings, and other source documents submitted from sites.  </li>
<li>Contact appropriate individuals (e.g., study site staff or study site Clinical Research Associate) regarding incomplete, inaccurate, or missing photos, acetate tracings, and other Endpoint and Specialty Services Core Lab documents as required by the project.</li>
<li>Oversee timely and accurate entry and cleaning of data for all study databases; maintain and file data management documentation as required.</li>
<li>Manage the acquisition and supply of project specific materials to study sites.</li>
<li>Provide feedback to study sites on tracing and quality issues, as required by project.</li>
<li>Manage and conduct Endpoint and Specialty Services CPC Core Lab activities.</li>
</ul>
  Here’s what you will need to bring to the table:
<ul>
<li>Nursing degree or BA/BS in a scientific field (or equivalent knowledge/experience)</li>
<li>3 years of experience in a clinical research setting (required) or 1 year of experience as a Research Assistant (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>Experience with clinical site startup preferred.</li>
<li>Proficiency in Microsoft Office, particularly Outlook, Word and Excel.</li>
<li>Excellent communication and organizational skills. </li>
<li>Great attention to detail. </li>
<li>Ability to interact with multiple individuals with varied skill sets in a positive, collaborative and educational manner.</li>
<li>Ability to adapt quickly to new situations, manage conflicts and resolve problems effectively.</li>
<li>Willingness to travel up to 25%.</li>
</ul>
Note: Viable applicants will be required to pass a background and education verification check.

Targeted Compensation: $61,114 - $77,000

Deadline to Apply: June 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 Operations Manager I

<h3>Job Description</h3>
Experic is an industry-leading contract development and manufacturing organization (CDMO) and clinical trial supply services company. Our vision is to deliver innovative and scalable solutions for every phase of a product's life cycle from clinical to commercial. We offer advanced pharmaceutical manufacturing, packaging, and labeling technologies that can accommodate a variety of dosing and packaging formats. We take pride in our precision capabilities, state-of-the-art filling equipment, advanced technologies, and Class A regulatory compliant cGMP facilities. Our main goal is to provide our clients personalized attention and ensure the smooth and successful completion of their pharmaceutical development programs. 

We aspire to develop a team culture based on trust, integrity, ethical behavior, and compliance, with a relentless focus on delivering high quality results. If you value a collaborative work environment and are energized by the opportunity to truly make a difference, come and Experience the Experic difference. We believe in fostering a fair and respectful work environment that encourages open communication and continuous improvement. At Experic, you can experience a fulfilling career, do meaningful work, and grow professionally and personally. A successful candidate will bring their unique thinking, expertise, and approach while sharing our core values.

This position is remote OR based in our Cranbury NJ office with flexibility to work from home 2 days/week. The successful candidate will be responsible for the project management of assigned clients including but not limited to the planning of project resources, assembling, or leading the project team, time management, budget, scope, quality and satisfaction, risk management, monitoring progress, documentation, and reporting.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
<ul>
<li>Management of project related activities from definition to launch stage to ensure that projects are delivered on-time, within approved budget and achieves project objectives.</li>
<li>Organize and lead project core team meetings.</li>
<li>Maintains effective communication and working relationships among project core team.</li>
<li>Ability to translate clinical trial synopsis / clinical trial protocol into an efficient and cost-effective plan including, but not limited to:</li>
<li>Material Management</li>
<li>Manufacturing, Packaging &amp; Labeling - Prepare documents such as, but not limited to, material specifications and batch records.</li>
<li>Prepare required distribution documentation, enter &amp; monitor shipments</li>
<li>Prepare required Returns, Accountability and Destruction documentation.</li>
<li>Manage all project related inventory to avoid stock out scenarios</li>
<li>Work with cross-functional team members to assess feasibility of project scope and objectives and develop detailed project timeline to ensure that there is enough flexibility and contingency in the plan to respond to unanticipated difficulties.</li>
<li>Define and assign schedules and track cross-functional tasks/activities to ensure that project progress within expected timings.</li>
<li>Management of monthly project invoicing.</li>
<li>Identify, monitor, communicate and resolve issues, scope changes, budget variances or other project objective hurdles that may arise during the project execution.</li>
<li>Interface with all functional areas of the business to ensure timely, effective, and efficient execution of project tasks.</li>
</ul>

ADDITIONAL POSITION REQUIREMENTS
<ul>
<li>Lead risk analysis &amp; mitigation planning for projects.</li>
<li>Prepare and present project progress reports and presentations as required.</li>
<li>Carries out duties in compliance with all federal and state regulations and guidelines.</li>
<li>Complies with all company and site policies and procedures including but not limited to safety, standard operating procedures, and work instructions.</li>
<li>Remains current in profession and industry trends.</li>
<li>Makes a positive contribution as demonstrated by:</li>
<li>making suggestions for improvement</li>
<li>learning new skills, procedures, and processes.</li>
<li>Is available for other duties as required.</li>
</ul>
QUALIFICATIONS: EDUCATION and/or EXPERIENCE
Bachelor's Degree preferred and three (3) years of project management experience in packaging, labeling and clinical supply chain as Project Manager or Project Coordinator; or six (6) years of project management experience in packaging, labeling and clinical supply chain as a Project Manager or Project Coordinator. Commercial packaging experience a plus.
LANGUAGE SKILLS
<ul>
<li>Read and interpret documents such as standard operating procedures, manuals, batch records, work instructions and specifications.</li>
<li>Legible Handwriting</li>
<li>Communicate clearly in writing and orally.</li>
</ul>

OTHER SKILLS, ABILITIES OR QUALIFICATIONS
<ul>
<li>Demonstrate practical knowledge of 21 CFR 210, 21 CFR 211, 21 CFR Part 11, Eudralex Volume 4 and Annex 13.</li>
<li>Demonstrate effective collaboration and teamwork.</li>
<li>Demonstrate experience managing contract pharmaceutical projects on time and on budget.</li>
<li>Demonstrate experience working in a cGxP environment.</li>
<li>Familiar with project management tools and technologies such as Microsoft Project.</li>
<li>Knowledge of various project management methodologies.</li>
<li>Successfully completes regulatory and job training requirements.</li>
<li>Computer skills:</li>
<li>Enter data into computer using software applications for data entry and word processing.</li>
<li>Work and be proficient with e-mail systems.</li>
<li>Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.</li>
<li>Ability to work with others in a team environment.</li>
</ul>

TRAVEL
<ul>
<li>Domestic travel will be required less than 5% of the time.
EXPERIC is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
</li>
</ul>

Clinical Supply Project Manager - Remote or Hybrid/Cranbury NJ

<h3>Job Description</h3>
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at <a href="http://www.abbvie.com" target="_blank">www.abbvie.com</a>. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 
Job Description
The Senior Manager, Clinical Data and Reporting Standards (CDARS) proactively participates in the development of data and reporting standards in support of AbbVie’s portfolio of clinical trials and ensuring AbbVie’s conformance to CDISC standards and industry best practices. This role implements the strategy and framework for governance of standards as set by the Head and Associate Directors of CDARS, and actively engages in deployment of next generation process and technology.
Standards Development responsibilities include:
<ul>
<li>Leading or participating in a cross-functional team of subject matter experts to define at least one of the following types of standards within the assigned therapeutic area:
<ul>
<li>Data Collection</li>
<li>Data Review Rules</li>
<li>SDTM mapping</li>
<li>ADaM mapping and derivation</li>
<li>Study-level tables, listings, or figures.</li>
<li>Product-level safety analysis displays</li>
</ul>
</li>
<li>Ensuring each standard is clearly defined, with appropriate documentation of relevant assumptions and decisions related to its use to support pipeline activities.</li>
<li>Support educating the organization on the proper use of standards in pipeline activities by contributing to the development of training materials.</li>
<li>Communicate ongoing standard development activities across the organization.</li>
</ul>
Pipeline responsibilities include:
<ul>
<li>Providing feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that support regulatory requirements to comply with CDISC standards (CDASH, SDTM and ADaM) and AbbVie standard extensions to CDISC.</li>
<li>Review and provide feedback on SDTM Trial Design Domains</li>
<li>Oversee the creation of SDTM define.xml, annotated CRF and Clinical Study Data Reviewer’s Guides for both FDA and PMDA submissions.</li>
<li>Consult on conformance issues for SDTM and/or ADaM and work with the study team to resolve the problem either by correcting the data or metadata, or by providing an appropriate explanation.</li>
</ul>
Other responsibilities include:
<ul>
<li>Representing AbbVie’s interests in industry standards development projects.</li>
<li>Staying current with industry standards such as CDISC, and the regulatory requirements related to their use.</li>
<li>Identifying improvements to the processes and content of standards and driving those improvements to completion.</li>
<li>May manage 3 or more direct reports.</li>
</ul>
This role can be based remotely anywhere within the U.S.
Qualifications
<ul>
<li>MS with 9 years of relevant clinical research experience, or BS with 11 years of relevant clinical research experience.</li>
<li>Experience leading development of standards for data collection, tabulation, analysis and/or reporting.</li>
<li>Experience with at least two of the following standards:  CDASH, SDTM, ADaM, Analysis Results Metadata, or TLF standards.</li>
<li>Active participation in CDISC teams preferred.</li>
<li>Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions.</li>
</ul>
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​
​
<ul>
<li>
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​
</li>
<li>
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
</li>
<li>
This job is eligible to participate in our short-term incentive programs. ​
</li>
<li>
This job is eligible to participate in our long-term incentive programs​
</li>
</ul>
​
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

Senior Manager, Clinical Data and Reporting Standards (Remote)

<h3>Job Description</h3>
SiteBridge Research, Inc:
Founded in 2021, SiteBridge Research is an integrated research organization, focused on building a national network of small and community medical practices to deliver world-class industry sponsored clinical research studies on time and on budget, accelerating time to completing clinical trials, accelerating time to market and product adoption in communities that are often underrepresented and difficult to reach. The SiteBridge Network extends reach further into these communities to empower patients with some of the highest unmet needs to take part in clinical studies to improve inclusivity in clinical research and to improve overall health outcomes.
Job Description: The Clinical Research Project Manager is an experienced research professional who will provide support and manage projects with, and under the direction of, the Director of Clinical Research Coordinators &amp; Project Managers for multiple ongoing studies within our site network. This role requires in-depth industry understanding, knowledge, experience, and flexibility to make informed and effective decisions independently. The Clinical Research Project Manager will be responsible for identifying, developing, and gathering the necessary resources to complete clinical research projects and coordinate the project’s start-up, maintenance, and close-out activities. They will be required to work closely with the site staff to ensure the deliverables and timelines are met. In addition, and most importantly, this role represents SiteBridge Research’s mission and vision by focusing on the trusted physician/patient partnership from start to finish for every clinical trial conducted at the site and is key in transforming clinical research for every participant. The position will maintain the operational excellence required of clinical sites/staff involved in clinical studies and ensure ICH/GCP and SOP compliance. This role will report to the Director of Clinical Research Coordinators &amp; Project Managers and the Head of Clinical Operations. This position is remote with up to 40% travel for candidates with the prerequisite experience.
Responsibilities: 
<ul>
<li>Work closely under the direction of the Director of Clinical Research Coordinators &amp; Project Managers to coordinate project start-up, maintenance, and close-out activities (including but not limited to study start-up and close out, recruitment, and regulatory submissions) </li>
<li>Work collaboratively with the Clinical Operations leads, Project Managers, and site team to ensure project deliverables are completed.</li>
<li>As necessary, step in and fill site and study level needs (including but not limited to site set-up and CRC duties to meet SBR and sponsor needs)</li>
<li>Ensure ongoing communication to team members of the scope of work, timeline and project goals, technical information, and input from study teams throughout the project, including significant changes in resourcing, scope of work, and timelines</li>
<li>Evaluate and communicate metrics of all activity related to assigned projects </li>
<li>Consult with SiteBridge Leads to determine the best course of action for projects related to the site and trials </li>
<li>Effectively communicate with physicians, sponsors, stakeholders, and study staff as related to assigned projects</li>
<li>Track study activities to ensure compliance with standard operating procedures (SOPs), protocols, and all related local, state, and national regulatory and institutional policies </li>
<li>Maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, and communicating to the team in an open, balanced, and objective manner</li>
<li>Prepare, participate in, and follow-up on audits/inspections as needed</li>
<li>Participate in required training and education programs.</li>
<li>Participate in meetings (i.e., Investigator Meetings, Site Trainings, Conferences) and seminars to update knowledge of clinical research and related issues as necessary </li>
<li>Other duties and support as assigned related to site and study operations</li>
<li>Travel is required (up to 40%) for projects related to site development and operations</li>
</ul>
Qualifications/Required Experience: 
<ul>
<li>Minimum Bachelor's degree; a combination of education and related technical/professional experience may be substituted for the degree requirement and will be considered on a case-by-case basis</li>
<li>Minimum of 4 years of clinical research or related experience; experience as CRC, CRA, or related is required</li>
<li>Minimum of 2 years of Project Management experience highly preferred </li>
<li>Bilingual, Spanish speaking candidates are encouraged to apply</li>
<li>Proven success managing and integrating multiple projects across an organization</li>
<li>Demonstrated knowledge of clinical trials project management and execution related to but not limited to start-up, regulatory submission, site feasibility, etc.</li>
<li>Excellent working knowledge of FDA &amp; ICH GCP regulations and guidelines is required </li>
<li>Experience with eSource, eRegulatory, and CTMS is required</li>
<li>Experience in study document preparation (CRF, eSource, logs, SOPs, etc.) is a plus</li>
<li>Strong preference for experience within multiple phase research and therapeutic areas</li>
<li>Experience with necessary clinical study and staff records related to clinical study activity which includes case report forms, drug dispensation records, etc. </li>
<li>Excellent communication skills, attention to detail, problem-solving, follow through, and organizational skills, with the ability to multi-task and work under/meet deadlines </li>
<li>Detail-oriented and meticulous in all aspects of work </li>
<li>Superior interpersonal, organization, and management skills</li>
<li>Capable of working independently with minimal supervision</li>
<li>Understanding of medical terminology as well as standard clinical procedures and protocols </li>
</ul>
Additional Qualifications: 
<ul>
<li>Strong project and time management skills </li>
<li>High level of collaboration; customer-oriented awareness and focus </li>
<li>Skilled with standard computer programs including the MS Office suite </li>
<li>Strong interpersonal and written and verbal communication skills </li>
</ul>
Additional Information:
SiteBridge Research, Inc. is proud to be an Equal Opportunity Employer providing employees with a work environment free of discrimination and harassment. We respect and seek to empower each individual and value the diverse cultures, perspectives, skills, and experiences within our workforce. We celebrate diversity and do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability status, or any other applicable characteristics protected by law. All employment decisions at SiteBridge are based on business needs, job requirements and individual qualifications and performance.

Clinical Research Project Manager

<h3>Job Description</h3>
Salary: $72,000 - $90,000
We are looking for an experienced Clinical Operations Manager II to join our team! 

Are you well organized, but 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!
This role serves as the primary point of contact for industry sponsored clinical trials, Endpoint and Specialty Services activities and also provides operational support for biostatistics and programming deliverables.

Remote candidates are welcome to apply.
In this position you will:
<ul>
<li> Oversee clinical operations management activities. </li>
<li> Define and monitor project scope, timelines and deliverables from project initiation to close-out.</li>
<li> Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation.</li>
<li> Oversee trial-related activities.</li>
<li> Track and approve vendor payments.</li>
<li> Provide expert advice in the design, writing and/or review of all project-related essential documents including protocols, project management plans, case report forms, statistical analysis plans, project management plans, ICF templates, study procedure manuals, source documents, site newsletters, study reports, resource tools, essential documents, monitoring plans and report templates.</li>
<li> Develop and manage multidisciplinary project team members. Organize, plan for, and produce minutes for project team meetings.</li>
<li> Ensure the overall quality of project services and deliverables.</li>
<li> Provide necessary updates and reports to the sponsor as outlined by the contract.</li>
<li> Plan and oversee the execution of investigator meetings as contracted.</li>
<li> Work with the Business Development team on budgets, proposals and change orders.</li>
<li> Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact. </li>
<li> Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper. </li>
<li> Adhere to local, federal and international regulations, guidelines and CPC Policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs). Use appropriate discretion to proactively identify when there is a need to deviate from policies, procedures or plans and ensure deviations are appropriately documented.</li>
<li> Define and monitor Endpoint and Specialty Services scope, timelines and deliverables from project initiation to closeout with assistance from study assigned Clinical Operations Manager and the Head of Endpoint and Specialty Services.</li>
<li> Manage contracted deliverables for external committees (e.g. data safety monitoring boards, clinical endpoint committees), including but not limited to meeting scheduling, generation of meeting minutes and distribution of meeting materials.</li>
<li> Oversee SAE process and assure execution of safety plans.</li>
<li> Accurately track receipt, entry, upload and the processing of photos, acetate tracings, and other source documents submitted from sites. </li>
<li> Contact appropriate individuals (e.g., study site staff or study site Clinical Research Associate) regarding incomplete, inaccurate, or missing photos, acetate tracings, and other Endpoint and Specialty Services Core Lab documents as required by the project.</li>
<li> Oversee timely and accurate entry and cleaning of data for all study databases; maintain and file data management documentation as required.</li>
<li> Provide feedback to study sites on tracing and quality issues, as required by project.</li>
<li> Manage and conduct Endpoint and Specialty Services CPC Core Lab activities.</li>
<li> Provide operational support for the biostatistics and programming deliverables.</li>
</ul>
Here’s what you will need to bring to the table:
<ul>
<li> Nursing or BA/BS in a scientific field (or equivalent knowledge/experience).</li>
<li> 4 years of experience in a clinical research setting, preferably with at least 2 years of project/operations management experience in clinical research.</li>
<li> Demonstrated ability to adequately manage all facets of a clinical trial with minimal direction.</li>
<li> Thorough knowledge of the Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials.</li>
<li> Proficiency in Microsoft Office, particularly Outlook, Word and Excel.</li>
<li> Excellent communication and organizational skills.</li>
<li> Great attention to detail. </li>
</ul>
<ul>
<li>Exemplary skills leading and managing multi-disciplinary teams in a clinical research setting.</li>
<li>Ability to organize, instruct and oversee project staff, while promoting group effort and achievement.</li>
<li>Ability to adapt quickly to new situations, manage conflicts and resolve problems effectively.</li>
</ul>
<ul>
<li> Willingness to travel 20-25%.</li>
</ul>
Note: Viable applicants will be required to pass a background and education verification check.
Targeted Compensation: $72,000 - $90,000 annually
Deadline to Apply: June 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>.
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63 Remote Clinical Trial Manager Jobs