TMF Lead I
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Job Description
TMF Lead maintaining compliant, inspection-ready trial master files for Precision Medicine Group’s clinical research services. Managing TMF plans, audits, metrics, risks, and study close-outs.
Responsibilities:
- Ensure timely, high-quality TMF document review, processing, periodic quality review, setup, maintenance, finalization, and archival
- Create and execute study TMF Plans and project TMF Document Indexes
- Communicate TMF expectations, project-specific requirements, and changes to study teams
- Attend and contribute to project kick-off, internal, external, and ad hoc meetings
- Collaborate with Project Managers and Functional Leads to maintain inspection-ready TMFs
- Identify TMF compliance challenges, risks, gaps, and non-compliance; develop and implement mitigation plans
- Monitor and report TMF health, metrics, trends, risks, and overall status
- Serve as point of contact and Subject Matter Expert for project audits and inspections
- Provide TMF analytics and expertise to sponsors
- Ensure periodic quality reviews and document processing are completed for assigned projects
- Identify TMF training needs and provide or support team re-education
- Manage study close-out activities, including final document submission, query close-out, eTMF export, sponsor transfer, and receipt acknowledgement
- Manage projects within sponsor eTMF systems
- Monitor and report potential out-of-scope Records Management activities and support change orders
- Support and mentor less experienced TMF Leads
Requirements:
- Bachelor’s degree (or its international equivalent) +5 years of related experience, or equivalent combination of education, professional training and experience
- Working knowledge of FDA and ICH/GCP regulations and guidelines
- Ability to identify issues and escalate appropriately and effectively
- Excellent organizational skills and time management
- Ability to coordinate workload and meet established deadlines
- Ability to manage competing priorities effectively
- Working knowledge of relevant Precision SOPs and regulatory guidance, or ability to be trained and retain this knowledge
- Detail-oriented and able to work and plan independently and in a team environment
- Professional verbal and written communication skills
- Candidates must be legally authorized to work in the country of employment without employer sponsorship
Benefits:
- Equal Opportunity Employer
- Reasonable accommodation available for applicants with disabilities
- AI opt-out request available during the application process
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