30 days old

Trial Master File Specialist

MSC
Bethesda, MD 20814

Overview

Medical Science & Computing (MSC), a Dovel company, is an exciting growth oriented company, dedicated to providing mission critical scientific and technical services to the Federal Government. We have a distinguished history of supporting the National Institutes of Health (NIH) and other government agencies. MSC offers a dynamic and upbeat work environment, excellent benefits and career growth opportunities.

 

We attract the best people in the business with our competitive benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, Pre-Tax Transit Assistance and tuition reimbursement. If you enjoy being a part of a high performing, professional service and technology focused organization, please apply today!

 

Duties & Responsibilities

MSC is searching for a Trial Master File Specialist to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC and it is on-site in Bethesda, Maryland.

 

  • Assist with the development, implementation, and maintenance of the divisions Trial Master Files (TMFs) to meet regulatory requirements.
  • Provide support and guidance to various functional areas supporting the TMFs, both electronic and paper.
  • Provide support of the divisions TMF operations during eTMF implementation, audits, and/or regulatory inspections.
  • Ensure TMFs are \u201cinspection ready\u201d at all times and TMF documents are filed contemporaneously in a timely manner.
  • Monitor and identify study trends, communicate issues, and escalate concerns to the federal client.
  • Liaise with Regulatory, Quality, and other task area leads to reconcile TMF documents which have been received from various functional areas to ensure completeness and quality of files.
  • Ensure compliance with ICH, U.S. federal regulations, and division policies and procedures.
  • Assist in the tracking of all TMF activities (essential document submission and status).
  • Participate in working groups and team meetings, as required
  • Develop SOPs as required to ensure oversight of the division TMF process.

Requirements

  • MPH or Masters degree in Regulatory Affairs or a Clinical Trials field.
  • Minimum of one (1) to two (2) years of experience working in the TMF field is essential.
  • Additional experience in clinical trial management or clinical regulatory affairs is preferred.
  • Demonstrated experience developing SOPs and other formal documents.
  • Excellent communications skills, both verbal and written.

 

Medical Science & Computing (MSC), a Dovel company, is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

 

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Posted: 2020-09-22 Expires: 2020-11-19

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Trial Master File Specialist

MSC
Bethesda, MD 20814

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