Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are seeking a Trial Master File (TMF) Specialist to support the National Institutes of Health (NIH) in Bethesda, MD. This is an on-site position

This is a Full-Time long term contract position which offers:

- Competitive compensation and comprehensive benefit package

- Optional health, vision, and dental plans

- Vacation leave as well as 10 paid federal holidays and 401K plan.

- Access to NIH s unparalleled resources and niche scientific initiatives

TASKS/SERVICES

• Assist with the development, implementation, and maintenance of the Division of AIDS (DAIDS) Trial Master Files (TMFs) to meet regulatory requirements.
• Provide support and guidance to various functional areas supporting the TMFs.
• Provide support of DAIDS TMF operations during eTMF implementation, audits, and/or regulatory inspections.
• Ensure TMFs are inspection ready 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 various functional 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 DAIDS policies and procedures.
• Assist in the tracking of all TMF activities, which include essential document submission and status).
• Participate in working groups and team meetings, as required.
• Develop SOPs as required to ensure oversight of the DAIDS TMF process.
• Provide guidance and consultation on regulations, policies and procedures to DAIDS staff and collaborators.

REQUIREMENTS

• MS/MA in Biology or related discipline is required.
• Minimum of five (5) years of clinical research data management experience