TMF SPECIALIST I

Job Title
TMF SPECIALIST I
Location
Bethesda, MD 20817 US (Primary)
Category
Clinical Operations
Job Type
Full-Time
Education
Bachelor's Degree
Travel
None
Job 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.

Job 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 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.
• Ability to work in a fast-paced, deadline-oriented, rapidly changing, dynamic environment.
• Excellent written and verbal skills.
• Demonstrates strong planning and organizational skills.
• Mentors new personnel and may be involved in interviewing potential project staff.

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.