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 onsite in Rockville, MD.
Duties & Responsibilities
- Assist with the development, implementation, and maintenance of the Trial Master Files (TMFs) to meet regulatory requirements.
- Provide support and guidance to various functional areas supporting the program TMFs.
- Provide support of TMF operations during eTMF implementation, audits, and/or regulatory inspections.
- Ensure TMF’s 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 to ensure completeness and quality of files.
- Ensure compliance with ICH, U.S. federal regulations, and 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 TMF process.
- Provide guidance and consultation on regulations, policies and procedures to staff and collaborators.
- MS/MA in Natural Sciences is required.
- Minimum of three (3) to five (5) years of experience in positions of increasing responsibility in clinical operations, TMF or essential documents management.
- Solid understanding of global ICH GCP requirements, including the recent updates.
- Solid understanding of trial master files organization, implementation and archival including other relevant regulations and guidance to assure quality of TMFs.
- Prior regulatory inspection experience a plus.
- Good written and oral communication skills.
- Strong interpersonal capabilities and ability to build and maintain networks.
- Ability to anticipate and resolve problems effectively, experience implementing TMFs.
- Strong verbal communication and technical writing skills
- Organizational and interpersonal abilities; proficiency in technical/scientific writing
- Ability to lift boxed paper files for transport to/from meetings
Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.
Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.
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