Trial Master File Manager

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:

• Bachelor's degree in a scientific or healthcare discipline or comparable professional education
• 5+ years of clinical research experience at a biotechnology, pharmaceutical, or TMF vendor
• 2+ years of TMF management experience required, including the handling of clinical trial-related documents; experience with more than one eTMF platform is preferred but not mandatory
• Strong knowledge of the TMF Reference Model structure and core/country/site level essential documents
• Able to understand and comply with ALCOA+ standards, ICH/GCP guidelines, and Good Documentation Practices.
• Excellent organizational skills and attention to detail
• Effective communication and interpersonal skills
• Able to efficiently perform multiple tasks and manage changing priorities.
• Able to identify and solve logistical problems.
• Proficiency in Microsoft Word, PowerPoint, and Excel
• Able to build strong relationships with co-workers of various backgrounds and expertise

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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