Main Purpose of Job
The TMF Oversight Specialist will provide support for Trial Master File (TMF) activities to clinical study teams. This role will be responsible for the global oversight and day-to-day support of TMF activities, including setup and management of the TMF/eTMF, authoring, review, and approval of TMF Plans and other procedural documents, quality control (QC) and quality review of clinical documents, training on clinical document management and TMF business processes and the eTMF system, Veeva’s Vault, and vendor management and oversight of outsourced TMFs/eTMFs.
- Assist with the implementation and update of processes for clinical document management and clinical trial records (e.g., Trial Master Files).
- Use audit and quality review findings to assess current status across programs, studies, countries, or sites to evaluate inconsistencies, gaps, and trends in compliance of processes that might require process updates/improvements or re-training
- Apply knowledge of ICH-GCP, Code of Federal Regulations (CFR), and other national and local requirements to develop and improve document management processes
- Collaborate with functional area representatives to help ensure submission-readiness and inspection-readiness of TMFs, as needed
- Assist with or lead training across all relevant business units/functional areas on business processes around Clinical Document Management and the Trial Master File, eTMF system(s), and quality oversight of vendors
- Represent TMF Operations function on study teams.
- Management and maintenance of document rooms, including supporting filing, scanning, QC, and inventory of paper documents.
- Conducting and supporting ongoing inspection readiness TMF checks throughout studies to assess compliance with study-specific and organizational processes and ICH-GCP and applicable national and local regulations.
- Authoring and reviewing internal and external TMF-related SOPs and procedural documents as well as TMF Plans and associated documentation (e.g., TMF indexes, risk-based QC processes, etc.).
- Supporting internal and external audits and inspections including supporting study teams with locating and providing study documents, speaking to TMF processes, and assisting with addressing and resolving issues, as applicable.
- Management and maintenance of eTMF system, as needed.
- Participate in or lead TMF governance meetings with vendors to ensure oversight, compliance, and standardization across studies or programs.
- Assist with the development and reporting of metrics and KPIs related to inspection readiness, quality, TMF completeness, and performance.
- Work closely with study teams to help escalate and resolve issues identified as a result of quality reviews.
- Ad hoc support of activities within Clinical Development to help meet timelines and objectives. This may include support with archiving, document collection and processing, or start-up activities.
- A minimum of 6 years relevant clinical research (or related) experience within the pharmaceutical industry
- Thorough knowledge of ICH-GCP guidelines and applicability to all stages of the clinical development process
- End-to-end knowledge of clinical trials
- Knowledge and familiarity with industry workgroups and initiatives such as DIA Records Management Community (TMF Reference Model)
- Knowledge of applicable TMF and Document Management regulations and guidelines such as MHRA and EMA
- Vendor management experience
- Ability to work independently and within global, cross-functional team matrices
- Proficiency in Microsoft Word, PowerPoint, Project, Excel, SharePoint, Adobe Acrobat, and TMF and/or Document Management applications (e.g., eTMF, EDMS, etc.). Experience with other clinical systems preferred (e.g., CTMS, etc.).
- Prior experience supporting internal audits and/or Regulatory Authority inspections. The ideal candidate with have prior experience in a study or site management role (e.g., CTA, CRA/IHCRA, Study Manager, etc.) or in clinical quality assurance (e.g., GCP auditor), with an interest in Trial Master File and Inspection Readiness
Key behavioural Attritubes - All Staff
Openness and honesty
Readily offering information pertaining to work in hand whether positive or negative.
Being prepared to accept full responsibility for tasks entrusted to them; seeing tasks through to completion and dealing with the consequences of failure or success.
Being flexible to new ideas and approaches; changes of plans, objectives and/or priorities. Handling disjointed tasks effectively.
Being able to work productively with others to achieve tasks. Showing consideration for the needs and feelings of others.
Specific Behavioural Attributes
- Excellent written and oral communication skills, strong interpersonal skills, cost management, and expenditure analysis 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
- Strong interpersonal skills with an ability to work independently and as a team member
Education & Qualifications
- Bachelor’s Degree
- Travel may be required (5%)
Immunocore is an equal opportunities employer