TMF Specialist
Hays

Bethesda, Maryland

This job has expired.


The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position.

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

Our Client is seeking a TMF Specialist in Bethesda, MD.

Role Description

• Responsible for TMF set-up, quality management, reports, and metrics, and TMF quality
control/quality assurance.
• Accountable for overall TMF document quality and completion, including appropriate document
filing and maintenance, cross-functional document coordination, and TMF tracking and reporting
to internal and external clients.
• Ensures clinical trial documentation is consistent with eTMF specifications, ICH/GCP guidelines,
regulatory requirements, and applicable SOPs.
• Ensures that all new and updated record information is entered accurately and maintained in
accordance with TMF storage SOPs, processes, and data structure for inspection readiness.
• Ensures client requests for TMF retrieval, reproduction, and re-filing or requested records or
electronic images (e.g., PDF, jpeg) are met in a timely manner.
• Assists with the development and maintenance of the company's digital records/TMF training
materials, SOPs, and guidelines and may perform training of new and existing staff.
• Assists with inspection and audit ready activities.
• Maintains up-to-date knowledge of the TMF Reference Model, industry best practices, and
regulatory requirements.
• Serves as the liaison between eTMF records management and internal and external clients.
• Ensures deadlines, commitments, and goals are met by monitoring projects' daily activities.
• Serves as SME for project staff on TMF-related questions; determines methods and procedures
for new assignments and provides guidance or supervision of personnel and subcontractors,
including the oversight of day-to-day activities.
• QC reviews and approves documents to ensure that all new and updated documents are
accurately entered for inspection readiness.
• Coordinates retrieval of records requested by users and prepares closed studies for transfer to
final destination within agreed timelines.
• Assists management with implementation of plans, cost proposals, and resource projections for
records management projects.
• Ensures TMF is audit ready.

Skills & Requirements

• 1+ years of relevant clinical research and TMF experience at a biotechnology, pharmaceutical
company or CRO.
• Previous experience working in eTMF system software, Veeva Vault, and/or Transperfect Trial
Interactive TMF preferred.
• Understanding of clinical research concepts and processes.
• Strong knowledge of ICH-GCP guidelines and regulatory requirements related to clinical
document management.
• Strong organizational skills with outstanding attention to detail and follow through.
• Effective communications skills with internal and external customers.
• Highly resourceful and adaptable to effectively support multiple competing demands and
changing priorities while exhibiting the highest level of customer service.
• Proactive approaches to problem-solving with strong decision-making capabilities.
• Demonstrates knowledge of ICH, GCP, and other regulatory guidelines as applicable to the
management of clinical documentation.
• Demonstrates analytical skills to identify solutions to technical problems of varying complexity.
• Advises Project Team members on key TMF issues.
• Experience training, mentoring and coaching staff.
• Ability to build and maintain positive relationships with management, project teams, peers, and
subordinates.
• Demonstrates strong planning and organizational skills.
• Mentors new personnel and may be involved in interviewing potential project staff\
• Fully proficient in MS Office.
• Minimum B.A./B.S. degree in science/healthcare field required.

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays' guiding principles is 'do the right thing'. We also believe that actions speak louder than words. In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information. #1149061


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