TMF Manager 2019498
Location: Watertown, MA (Remote)
Science: Small Molecule
Therapeutic Area: Oncology
Job Overview: This role will be responsible for supporting the study management team with TMF process development, process implementation, and oversight of TMF management, working closely with the SMT Functional Area Leads and the Quality team to ensure smooth operations within the Clinical Operations department.
Primary Job Responsibilities:

• Act as the primary TMF contact and Subject Matter Expert (SME), supporting the clinical study team and cross-functional departments in TMF process education for an inspection-ready eTMF.
• Lead the development of SOPs, TMF-related plans, and system configurations, implementing process improvements and creating training tools.
• Maintain complete oversight of eTMF document filing, ensuring accuracy and compliance with company standards, Good Clinical Documentation Practices, and project-level Trial Master File Plan and Index.

• Bachelors Degree and at least 5 years of clinical experience, including successful oversight and management of electronic Trial Master Files for clinical trials.
• Demonstrate a high level of competence with Veeva VAULT eTMF and an in-depth knowledge of the TMF Reference Model as supported by DIA, with experience managing multiple TMFs with consistent quality and compliance with TMF regulations.
• Experience in TMF-related SOPs, templates, plans, and tools
• GCP inspection experience

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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