Trial Master File Manager

Rockville , MD
Jan 01, 2021
Jan 16, 2021
Full Time
Westat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments. Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in Rockville, Maryland, near Washington, DC.

Job Summary:
Westat is seeking a Trial Master File Manager who will be responsible for overseeing and performing daily Trial Master File (TMF) management activities relating to clinical studies, including ensuring regulatory inspection readiness and compliance with applicable laws and regulations. The TMF Manager will strategize the efficient and compliant paper and electronic storage, retrieval and protection of clinical records in compliance with U.S. Federal regulations.

Job Responsibilities:
• Develops and manages the processes and procedures for filing, retrieving, storing, preserving, and protecting clinical records across multiple concurrent clinical research studies.
• Oversees that all records are accurately catalogued and filed within established timelines; participates in document filing and document quality control.
• Ensures that the locations of all physical records are accurately captured and that all records can be readily retrieved.
• Manages the quality oversight of clinical records by performing, but not limited to, quality checks of TMF and supporting metrics and KPIs.
• Communicates with eTMF vendors on establishment of new studies and system functionality; reports systems issues and facilitates resolution.
• Collaborates with research teams and functional area staff to develop TMF plans and monitor plan compliance; leads and coordinates regular TMF team meetings.
• Participates in TMF audits, which lead to confirmation that the TMF is inspection-ready.

Basic Qualifications:
• A Bachelor's degree and 5 years of experience to include at least 4 years of experience supporting TMFs for multiple research studies and establishing TMF policies and procedures and developing study-specific TMF plans.

Preferred Qualifications:
• Expert knowledge of TMF systems for set-up, maintenance, and close-out.
• Solid knowledge of at least two eTMF vendor systems.
• Strong working knowledge of GCP/ICH regulations and guidelines.

Candidates should have strong attention to detail and excellent communication, organizational, time management, and project management skills. Possess strong critical thinking and logical problem solving ability, and communicate effectively with research teams, vendors, site personnel, auditors, and management. 

Westat offers a well-rounded and comprehensive benefits program focused on wellness and work/life balance. Eligible employees may participate in:
  • Employee Stock Ownership Plan
  • 401(k) Retirement Plan
  • Paid Parental Leave
  • Vacation Leave
  • Sick Leave
  • Holiday Leave
  • Professional Development
  • Health Advocate
  • Employee Assistance Program
  • Travel Accident Insurance
  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • Short Term Disability Insurance
  • Long Term Disability Insurance
  • Life and AD&D Insurance
  • Critical Illness Insurance
  • Supplemental Life Insurance
  • Flexible Spending Account
  • Health Savings Account

Westat is an Equal Opportunity Employer and does not discriminate on the basis of race, creed, color, religion, sex, national origin, age, veteran status, disability, marital status, sexual orientation, citizenship status, genetic information, gender identity or expression, or any other protected status under applicable law.

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