Trial Master File Specialist
We are currently 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, MD.
Duties & Responsibilities
- Manage Trial Master File program for all program studies. Develop protocol-specific TMF indexes and plans at trial start, collect and file TMF documents throughout the trial, correspond with TMF CRO support during and after the trial, and ensure QC of final TMF at the end of the trial.
- Advise, coordinate and plan scientific research activities for Phase I and II clinical trials for investigational vaccines and monoclonal antibodies targeting infectious diseases including influenza, HIV, malaria, etc.
- Serve as a clinical protocol study team member, will actively engage in protocol planning and development and development and assessment of domestic and international sites.
- Develop processes and SOPs and other documents to support TMF management.
- Ensure adherence to processes and SOPs specific to documents under their management.
- Ensure documents are readily available for audits and inspections.
- Participate in internal or external audits and regulatory authority inspections as needed.
- Provide guidance and serve as a TMF resource to colleagues.
- Draft, edit, and review protocols and operations manuals specific to the research projects.
- Provide scientific and regulatory guidance and assistance to the program in support of product development.
- Review and provide input on various research agreements (interagency agreements, clinical trial agreements, etc.) to ensure the program’s needs are met.
- Master’s Degree in a related filed OR Bachelor’s Degree with applicable job experience may be considered.
- Regulatory Affairs Certification (RAC) preferred.
- Minimum five (5) years of experience in the pharmaceutical/biotechnology industry, government, or equivalent, including a minimum of three (3) years clinical document management system experience, preferably with drugs or biologics products.
- Experience participating in internal or external audits and regulatory authority inspections preferred.
- Demonstrates knowledge and understanding of GCP, ICH guidelines and, regulatory requirements for clinical research and TMFs.
- Ability to work independently and as part of a team.
- Strong organizational skills.
- Excellent oral and written communication skills.
Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.
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