Remote opportunity at
Precision Medicine GroupTMF Lead I
Precision Medicine Group seeks a remote TMF Lead I to support project teams in maintaining high-quality trial master files according to Good Clinical Practice, regulatory guidelines,…
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About This Role
Precision Medicine Group seeks a remote TMF Lead I to support project teams in maintaining high-quality trial master files according to Good Clinical Practice, regulatory guidelines, and internal standard operating procedures. This role ensures that document review, periodic quality checks, setup, maintenance, finalization, and archiving are handled promptly and accurately. The person in this position will create and execute study trial master file plans and document indices, communicate changes to…
Job Description
Precision Medicine Group seeks a remote TMF Lead I to support project teams in maintaining high-quality trial master files according to Good Clinical Practice, regulatory guidelines, and internal standard operating procedures. This role ensures that document review, periodic quality checks, setup, maintenance, finalization, and archiving are handled promptly and accurately. The person in this position will create and execute study trial master file plans and document indices, communicate changes to the team, and collaborate with project managers and functional leads to keep records inspection-ready.
Candidates will proactively spot compliance challenges, monitor health metrics, manage study close-out activities, and act as a subject matter expert during audits or inspections. This fully remote position suits professionals with strong organizational skills who can handle competing priorities and mentor less experienced team members. Precision Medicine Group is an equal opportunity employer committed to fair employment practices.
Responsibilities
- Ensure timely and high-quality document processing, periodic reviews, setup, maintenance, finalization, and archiving of study trial master files
- Develop and execute study trial master file plans and document indices while managing team communication regarding any updates
- Collaborate with project managers and functional leads to maintain an inspection-ready state and submit documentation promptly
- Anticipate compliance risks, track health and metrics, and follow escalation processes when non-compliance arises
- Serve as a subject matter expert during project audits and inspections and assist with report responses
- Manage study close-out tasks including timeline definitions, final document processing, query resolution, and sponsor transfers
- Support and mentor less experienced trial master file leads with role performance and problem-solving
Requirements
- Working knowledge of FDA and ICH/GCP regulations and guidelines
- Legal authorization to work in the country of employment without employer sponsorship
Qualifications
- Bachelor’s degree or international equivalent plus five years of related experience
- Equivalent combination of education, professional training, and experience providing the required skills
Core Skills
Frequently Asked Questions
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Is this position remote?
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The job posting indicates that this is a full-time position.
What salary is offered for this role?
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What are the minimum education and experience requirements?
Candidates must have a bachelor's degree or its international equivalent plus five years of related experience, or an equivalent combination of education, professional training, and experience.
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