Manager, Trial Master File
Department: Clinical Operations
Reports to: Vice President, Clinical Operations
Reporting to the Vice President, Clinical Operations, the TMF Manager will provide the leadership, subject matter expertise, vendor oversight, and clinical study team support required to ensure that the electronic (eTMF) and paper (TMF) Trial Master Files are managed and maintained in accordance with relevant ICH guidelines, GCP regulatory requirements, and other regulations, as appropriate. This involves the development of any Standard Operating Procedures (SOPs), work instructions, and QC practices relevant to the management of the eTMF, as well as oversight for, and hands-on management of, the eTMF and TMF (together TMF) contents of TMFs held both internally and at CROs. The TMF Manager monitors and manages overall performance of the TMF build and certification process to drive quality and compliance across the organization. S/he will be responsible for TMF quality, compliance, and inspection readiness, and contributes to decision-making authority for the overall TMF build and certification processes.
At the departmental level, the TMF Manager will contribute to the development and revision of relevant SOPs and internal processes. The TMF Manager will formulate recommendations to Clinical Operations leadership on complex and important problems as they arise. The TMF Manager will take on a leadership role by acting as a resource and providing mentorship to less-experienced colleagues.
General Responsibilities and Required Skills:
Displays well-developed leadership qualities
Possesses a solid understanding of Clinical Operations and Drug Development
Ensure that the electronic (eTMF) and paper (TMF) Trial Master Files are managed and maintained in accordance with relevant ICH guidelines, GCP regulatory requirements and other regulations, as appropriate
Proactively seeks out and recommends process improvements
Proven track record of anticipating potential TMF issues and preparing contingency plans with little oversight
Communicates clearly and effectively with internal and external key stakeholders
Routinely mentors and may supervise junior staff; takes a leadership role in onboarding new personnel
Escalates issues in a timely and appropriate manner
Oversee the quality and integrity of all internally and externally held TMFs at a cross-functional level to ensure SOP and regulatory requirements are met
Serve as the business owner of the TMFs
Manage the creation of the TMF management tools in compliance with regulations
Ensure the maintenance of all study TMFs in a constant state of inspection readiness
Manage and ensure appropriate level of sponsor oversight of CROs and vendors with TMF responsibility, ensuring adequate follow up, resolution and documentation of identified issues
Maintain TMF Management Plans and TMF Indexes and Content Lists; work with the Study Teams to check and verify the plans
Provide guidance on best practices for record handling, retrieval, and archival procedures
Prepare and maintain manuals, training materials, policies and procedures, and other quality documents as they apply to the management of records
Manage creation of TMF/eTMF filing locations based on the study specific TMF Index
Manage and participate in Quality Control periodic assessments of documents (paper and electronic) submitted to the TMFs
Responsible to track eTMF periodic reviews throughout each study’s lifecycle and provide regular updates of findings and resolutions to the leadership team
Manage the transfer of study-specific trial master files from the CROs
Participate in Study Team meetings
Maintain awareness of study events and the associated documentation requirements through collaboration with Study Teams
Support Study Teams in understanding their TMF-related responsibilities, requirements, and expectations
Subject Matter Expert for TMF questions
Manage TMF document retrieval during Audits and Inspections (paper and electronic).
Manage the TMF Index(s)
Provide TMF metrics: completeness and quality of TMF documentation and content, including the percent completeness and the risk level of outstanding items on a periodic basis or as requested.
Review metrics to monitor performance against targets to ensure Key Performance Indicators (KPIs) are being met and productivity is aligned with senior leadership and regulatory authority expectations
Identify any corrective actions which must be addressed and assigned.
Support the management of TMF documentation issues throughout the lifecycle of an assigned study.
Provide archived records to users (e.g. internal staff and/or Auditors) for review; oversee the provision of the required documents at the time of Regulatory Authority Inspection or internal Audits
Respond to TMF and non-TMF internal and/or external information inquiries related to Clinical Trial records
Continuously evaluates compliance to applicable SOPs and the quality of the TMF/eTMF; develops corrective action plan if indicated
Conduct risk management assessments throughout the life of the trials, proposing mitigation strategies as necessary
Manage TMF audit process
Oversee TMF close-out processes and archival processes ensuring all issues are addressed appropriately
Contribute to the development and continuing process improvement of relevant SOPs and internal processes
Identify opportunities for continuous process improvement
Other duties as assigned
Bachelors’ degree in scientific/clinical related discipline
8+ years of relevant pharmaceutical industry experience in developing and managing electronic and paper TMFs within the pharmaceutical industry
Must enjoy working in a fast-paced, innovative environment. Must be flexible, proactive, and efficient
Familiarity with the DIA Reference model and a demonstrated understanding of records management best practices
Extensive knowledge of clinical documents that are maintained in the eTMF
In-depth understanding of industry standards including ICH guidelines, GCP, compliance, the CFR, and major Health Authority regulations as they pertain to the operational aspects of clinical studies and the management of TMF content
Functions independently with some oversight and willing to “wear many hats”
Local within commuting distance so can come to office occasionally
Excellent communication, writing, and presentation skills
Ability to foster effective relationships with vendors and colleagues
Strong critical thinking skills
Strong attention to detail, organizational and time management skills, and the ability to establish priorities
Experience preparing for and being part of GCP compliance audits/assessments/document reviews
8+ years of relevant industry experience
Knowledge of the infrastructure and operational characteristics of CROs and centralized services
Understands the roles/responsibilities and inter-dependencies for key functions involved in clinical development
Significant vendor management experience, including oversight of CROs
Relevant certification, such as Registered Quality Assurance Professional, Certified Quality Auditor, CCRA or CCRC, Certified Clinical Research Professional, or Regulatory Affairs Certification
Small pharma experience
Experience with pain or CNS trials
Prior NDA inspection readiness and regulatory inspection experience is highly desired
Work Environment: Office
Physical Demands: Occasional overnight travel
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.
To apply, please send an email with your resume and cover letter to firstname.lastname@example.org.