Trial Master File Manager
Company: Westat
Location: Rockville
Posted on: January 12, 2021
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Job Description:
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.
Keywords: Westat, Rockville , Trial Master File Manager, Executive , Rockville, Maryland
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