Trial Master File (TMF) Owner
Immunocore, USA (Location: Conshohocken, PA or Rockville, MD)
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.
The Trial Master File (TMF) Owner is responsible for the company’s TMF processes including the implementation and overall management of both paper-based and electronic processes and systems (e.g., eTMF system), day-to-day operations, development and oversight of TMF procedural documents such as TMF SOPs and standards, and development and generation of reports and key performance indicators to measure completeness, accuracy, and timeliness of study documents with a strong focus on ensuring that document management operations are performed in accordance to company standard operating procedures (SOPs), ICH-GCP and regulatory guidelines.
- Primary point of accountability for the company’s Trial Master File processes and systems.
- Develop global standards, standard operating procedures (SOPs) and corresponding controlled documents that are in line with relevant regulatory regulations (e.g., ICH-GCP, and regulatory requirements such as EMA and MHRA) and industry best practices (e.g., TMF Reference Model).
- Evaluation, implementation, and management of the company’s eTMF system and TMF Operations functional area representative for the implementation of any systems or processes that would interface/integrate with eTMF (e.g., CTMS, EDMS, CDMS/EDC, etc.).
- Training administration of TMF and document management-related business processes.
- Development, review, and/or approval of study-specific TMF procedural documents (e.g., SOPs) and TMF management plans and TMF Indexes in collaboration with IMC internal and external (third party vendor) functional/sub-functional area study team members.
- Conduct inspection readiness checks/quality reviews of TMF documents and across sections of the TMF (e.g., trial, country, site) and work with internal and external team members to ensure that any findings are resolved satisfactorily and within a timely manner.
- Develop, implement, and provide standard TMF metrics/KPIs to demonstrate document quality, TMF completeness, and process compliance.
- TMF Operations point of contact for any questions related to TMF processes and systems and study-specific TMF support, as appropriate.
- Supporting internal and external audits and inspections, may include but is not limited to, supporting teams with document retrieval during audit/inspection, managing training and access to eTMF system to inspectors, as needed, presenting on departmental or study-specific TMF processes, etc. Coordinating the transfer of any study-specific TMFs/eTMF from third party vendors as required by the TMF Plan
- Ownership of the eTMF system, Veeva Vault, and the management and maintenance of the system, includes but is not limited to; ongoing configuration change and release management according to change control and computer systems validation (CSV) processes, account and access management, setup and maintenance of study data in the system, quality checks of study documents, development of standard reports and dashboards to measure TMF quality, completeness, and user performance.
- Develop and implement tools and processes to support the eTMF system such as training materials, user guides, checklists, QC materials, etc.
- Identify, evaluate, and implement archival vendors and processes for the Trial Master File.
- Coordinate or support off-site archival of clinical study documents as well as requests for retrievals from off-site archival.
- Represent the - TMF Operations function at meetings and on study teams.
- Develop and implement document Management facilities and related document management room processes.
- Establish governance structure around the Trial Master File with preferred vendors, e.g., clinical CRO and third party vendors, and ensure management level oversight related to TMF activities and deliverables.
Experience and Knowledge
- Advanced understanding of ICH-GCP, and regulatory requirements as they apply to the Trial Master File
- Advanced end-to-end understanding of clinical trial phases involved in drug development and corresponding document requirements.
- Previous experience supporting regulatory inspections.
- Previous experience in document management and electronic TMF systems (e.g., Wingspan, Trial Interactive, Veeva Vault, Documentum, etc.)
- Previous experience implementing off-the-shelf eTMF systems and associated processes is required.
- Ability to work independently with minimal supervision and within global, cross-functional team matrices
- Experience in oversight and management of vendors
- Experience in managing people and/or contracted resources
- Knowledge and familiarity with industry workgroups and initiatives such as DIA Records Management Community (TMF Reference Model)
- Excellent written and oral communication skills and strong interpersonal skills
- Possesses excellent time management and organization skills
- A commitment to producing high-quality work with an attention to detail
- Demonstrated ability to problem solve and use clear judgement in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies
- Experience with other clinical systems preferred (e.g., CTMS, document management systems, etc.).
- Prior experience with Veeva Vault eTMF and/or other Veeva products
- Additional knowledge of and experience with regulatory requirements (BLA/MAA submissions) and quality systems preferred
Education & Qualifications
- BA or Bachelor of Science. in science related field (biological science, medical, pharmacy or other health related discipline),
- Advanced degree preferred
- At least 8 years relevant clinical research (or related) experience in a biotechnology/ pharmaceutical industry and/or clinical research organization in Clinical Operations and/or with a focus on Trial Master File/Clinical Document Management
- Demonstrated computer skills; proven functional knowledge of Microsoft packages (such as but not limited to Microsoft Word, PowerPoint, Project, Excel, SharePoint, Adobe Acrobat) and TMF and/or Document Management applications (e.g., eTMF, EDMS)
- Travel may be required (5%)
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.