Responsibilities:

• 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.

Requirements:

• Minimum B.A./B.S. degree in science/healthcare field required.
• 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.

Job Snapshot