What are the responsibilities and job description for the Trial Master File Manager position at Bayside Solutions?
Trial Master File Manager
W2 Contract
Location : South San Francisco, CA - Hybrid Role
Job Summary :
As a Trial Master File (TMF) Manager, you will ensure the completeness and accuracy of the TMF for all sponsored clinical trials. You will provide expert guidance in TMF management and work closely with the cross-functional study teams and Contract Research Organizations (CROs) to ensure the timely and accurate delivery of TMF-related deliverables in compliance with ICH / GCP guidelines, regulatory requirements, and internal policies.
Duties and Responsibilities :
- Oversee CRO-managed TMF activities for sponsored clinical trials and drive a culture of quality and compliance that aligns with ICH / GCP guidelines, regulatory requirements, and internal policies.
- Partner with cross-functional study teams and CROs to ensure timely set-up, maintenance, and close-out of TMFs.
- Co-author and review TMF documents, such as TMF Plans, eTMF Index, Standard Operating Procedures, and other guidance documents.
- Provide input on Expected Document Lists and study milestones to measure TMF completeness.
- Support eTMF system updates by participating in system enhancement discussions, user acceptance testing, change control-related processes, and reviewing release notes.
- Manage the TMF quality review process and partner with the study teams to resolve queries, issues and document discrepancies.
- Oversee the TMF performance metrics and drive actions when issues and trends are identified.
- Develop and deliver ongoing TMF training to cross-functional stakeholders to share lessons learned and best practices (e.g., process, quality, system, etc.).
- Work with study teams to develop and maintain TMF storyboards.
- Collaborate with the study teams to archive TMFs and confirm access to currently archived TMFs.
- Provide subject matter expertise and TMF guidance during audits and inspections.
Requirements and Qualifications :
Desired Skills and Experience
Trial Master File, TMF, eTMF, clinical trials, clinical research, ICH guidelines, GCP, Microsoft Office
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.
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