Clinical Trial Manager (CTM)
Conshohocken, PA or Rockville, MD
Immunocore is an innovative and dynamic biotechnology company developing a unique platform of T Cell antigen receptor-based therapeutics, called ImmTAXs, as a novel class of treatments for cancer, infectious and autoimmune diseases.
Immunocore has a well- established pipeline of wholly owned programmes, of world leading science and strong IP position, which has led to discovery collaborations with Genentech, GlaxoSmithKline, Medimmune as well as a co-discovery & co-development partnership with Lilly, and recent investment from the Bill & Melinda Gates Foundation.
The Clinical Trial Manager is 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 lmmunocore Clinical Project Manager (CPM), Clinical Research Organization (CRO) representative(s), vendors and other lmmunocore functional departments (as required) to drive start-up and ongoing oversight of clinical studies.
This position can be located in the Conshohocken, PA office or Rockville, MD.
- Participate in the planning, implementation and management of lmmunocore clinical trials/assets in compliance with industry regulations, ICH-GCP and applicable lmmunocore 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-lnvestigator - 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 lmmunocore CPM and lmmunocore Medical Monitor for country and site identification, feasibility and selection to optimize processes to ensure efficient start-up timelines are met.
- Support study start up in collaboration with internal and external project teams (e.g. lmmunocore 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.
- Support 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
- Support Immunocore CPM to ensure consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate.
- Contribute to the development and/or participate in the review of study related documents including (but not limited to) site feasibility, informed consent documents (site specific), monitoring plans, regulatory and start-up plans, patient recruitment plans, pharmacy and lab manuals 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 oversee implementation of patient recruitment and retention strategies and acts on any deviations from plan.
Experience & knowledge
- Minimum 5 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
- Ability to work independently with minimal supervision
- Experience presenting high level presentations, both orally and in writing
- Travel - 15%
Education & qualifications
- Educated to degree level (biological science, pharmacy or other health related discipline)
- Demonstrated computer skills; proven functional knowledge of Microsoft packages and ability to develop proficiency in relevant Immunocore IRT and EDC systems and programs
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.