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.
Primary Job Requirements:
Bachelor's 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:
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