TMF Lead II
VirtualVocationsWorcester, Massachusetts, United Statesjob_description.job_card.1_day_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.full_time
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A company is looking for a TMF Lead II.
Key Responsibilities :
Manage and support the Trial Master File (TMF) throughout the lifecycle of clinical studies
Ensure TMF health, completeness, and compliance with ICH / GCP guidelines
Oversee the preparation of the TMF for audits and inspections, and maintain audit readiness
Required Qualifications :
BS / BA degree in a related discipline with 6-7 years of experience, or MS / MA degree with 3 years of experience, or equivalent combination of education and experience
Minimum 7 years of experience in a clinical research environment
5+ years of experience in TMF management
Clear understanding of GCP and ICH guidelines
Knowledge of regulatory / clinical document requirements and proficiency in Microsoft Office and related software
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Ii • Worcester, Massachusetts, United States
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