Trial Master File Specialist

A company is looking for a Sr. Specialist, Global TMF. Key Responsibilities Lead the development and maintenance of the Trial Master File (TMF) Plan and Index Collaborate with project and functional leads to ensure timely and high-quality TMF documentation Generate monthly TMF metrics reports and oversee TMF compliance and filing accuracy Required Qualifications BA with 4+ years of experience or High school diploma with 6+ years of experience in a clinical research environment Trained in clinical research regulatory requirements including ICH and GCP Proficient in Microsoft Office Suite and knowledgeable in Veeva Clinical Vault (eTMF) Strong organizational, planning, and decision-making skills Ability to establish and maintain effective working relationships with clients

Apr 3, 2025 - 19:31

A company is looking for a Sr. Specialist, Global TMF. Key Responsibilities Lead the development and maintenance of the Trial Master File (TMF) Plan and Index Collaborate with project and functional leads to ensure timely and high-quality TMF documentation Generate monthly TMF metrics reports and oversee TMF compliance and filing accuracy Required Qualifications BA with 4+ years of experience or High school diploma with 6+ years of experience in a clinical research environment Trained in clinical research regulatory requirements including ICH and GCP Proficient in Microsoft Office Suite and knowledgeable in Veeva Clinical Vault (eTMF) Strong organizational, planning, and decision-making skills Ability to establish and maintain effective working relationships with clients