Senior Clinical Trial Manager (CTM)
Conshohocken, Pennsylvania, United States
Senior Clinical Trial Manager (CTM)
Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease. We are developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs.
It is an exciting time to join Immunocore. Our most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies. The company also recently completed its Initial Public Offering and was listed on the NASDAQ.
This position is office based in the Conshohocken, PA or Rockville, MD office.
The Senior Clinical Trial Manager will be responsible for managing clinical trial sites from study start-up throughout the course of the clinical trials until site close out. They will work to oversee that all aspects of the conduct of the trial sites and or across their assigned assets are in compliance with the study protocol, study operation plans, ICH current GCPs, and regulatory requirements. They will work collaboratively with the Immunocore Clinical Project Manager (CPM), Clinical Research Organization (CRO) representative(s), vendors and other Immunocore functional departments (as required) to drive start-up and ongoing oversight of clinical studies. They may have direct reports of Clinical Trial Managers across the clinical operations portfolios ensuring their clinical program deliverables are delivered to time, cost and quality.
- Participate in the planning, implementation and management of Immunocore clinical trials/assets in compliance with industry regulations, ICH-GCP and applicable Immunocore controlled documents.
- Oversee the site management of CROs and clinical trial sites to ensure delivery, per scope of work or contractual agreements, meet recruitment targets and deliver high quality data on time.
- Track site visit and trip report metrics; data quality concerns and site level trending of protocol deviations.
- Conduct oversight site visits including pharmacy visits, as required, to evaluate site and CRA performance and ensure adherence to study protocols, study operation plans, ICH GCP and regulatory requirements
- Attend and assist, as required, at Initiation visits to confirm site training of therapeutic indication(s) and associated study procedures (e.g. Pharmacy training) and help build and foster sponsor-CRO-Investigator - site relationships
- Review a percentage of CRA monitoring trip reports, ensuring oversight of CRO CRA and Site compliance with protocol, study plans, SOPs and ICH and GCPs, escalate identified report issues and ensure CRO study team resolve identified concerns
- Collaborate with Immunocore CPM and Immunocore Medical Monitor for country and site identification, feasibility and selection to optimize processes to ensure efficient start-up timelines are met.
- Manage study start up in collaboration with internal and external project teams (e.g. Immunocore Project Manager, Regulatory, Clinical Supplies, Third Party Vendors, CRO) to ensure start up timelines are clearly defined and implemented, working to identify any risks and resolving any issues.
- Act as subject matter expert for assigned protocols for study related issues, protocol and clinical operational queries arising from CRO, IRB/IECs/RAs, Third Party Vendors and sites.
- Provide routine updates to the internal project team on study status/issues
- Manages the CRO/clinical trial site during start-up activities including, but not limited to, budget and contract negotiations, IRB/EC submissions and response and facilitation of essential document collection
- Provide direction and support to the CPM in ensuring consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate.
- Manages consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate
- Works cross-functionally with other Immunocore departments (Clinical Supplies, Quality Assurance, Regulatory Affairs) to ensure all clinical trial activities performed by Immunocore as a Sponsor are performed according to study requirements and timelines.
- Contribute to the development and/or participate in the review of study related documents including (but not limited to) site feasibility, protocol, informed consent documents (master and/or site specific), budgets, monitoring plans, regulatory and start-up plans, patient recruitment plans, pharmacy and lab manuals, case report form development and training materials
- Execute and/or deliver trial specific training as required
- Review of open action items and data trends; working with CROs to escalate and resolve identified issues to ensure standards for monitoring and reporting are met as well as to ensure better efficiencies and execution of our studies.
- Contribute to the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan.
- Oversight of direct report(s) study execution and procedures as required to ensure regulatory compliance of protocol activities, if appropriate
- Accountable for ensuring all study deliverables and milestones are met with quality and within timelines
- Provide direction and support to direct report(s) to ensure consistent approach and process to study execution and procedures amongst various program assets
- Provides support/escalation point for direct reports as needed
Experience & Knowledge
- At least 8 years of relevant clinical operational experience in a biotechnology/pharmaceutical company, and/or CRO
- Working knowledge of GCP, ICH, GDP and relevant CFRs is required; familiarity with MHRA/EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus
- Experience with start-up and initiation of clinical trial sites
- Experience creating and maintaining healthy and creative relationships with clinical trial sites and Principal Investigators, helping to support and influence where required
- Ability to communicate and coordinate activities with the internal team, clinical sites and vendors
- Proactively identify project challenges/risks and appropriate corrective actions to the internal study teams and work with internal team, clinical sites and vendors on resolutions with minimal supervision
- Ability to work independently
- Experience presenting high level presentations, both orally and in writing
- Knowledge of and experience with immunotherapies and/or Oncology
- At least 2 years of on-site monitoring experience
Lead with Science and Discover What is Within:
- We value Entrepreneurship and Diversity
- Respect, Trust, and Integrity
- Competitive compensation
- Medical and vision benefits, beginning your first day of employment
- Fully paid Dental Insurance
- 20 days’ vacation plus holidays
- Fully paid Life Insurance and Disability
- 401(k) with Company Match
Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position.
Immunocore is an E-Verify employer.