Dexian · 15 hours ago
TMF Specialist
Bethesda, MD
Full-time
Onsite
Mid, Senior LevelDexian stands at the forefront of Talent + Technology solutions, and they are seeking a TMF Specialist. The role is responsible for TMF set-up, quality management, and ensuring clinical trial documentation meets regulatory requirements and industry best practices.
ConsultingHuman ResourcesInformation TechnologyProfessional ServicesStaffing Agency
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 accurately entered and is maintained in accordance with TMF storage SOP's, 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, SOP's, 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, costs proposals and resource projections for records management projects
Ensures TMF is audit ready
May include task management and/or line management responsibilities, depending on experience level
Qualification
Required
Previous experience working in eTMF system software, Veeva Vault/Trial Interactive 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 customer
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
Fully proficient in MS Office
Minimum B.A./B.S. degree in science/healthcare field required
Company
Dexian
Dexian provides services for staffing, talent development, and consulting, with a focus on technology, finance, and project management.
Founded in 1994
1001-5000 employees
H1B Sponsorship
Dexian has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (65)
Funding
Current Stage
Late StageLeadership Team
Mahfuz Ahmed
Chairman of the Board
Vikram Motiani
Managing Director
Recent News
2025-11-19
Company data provided by crunchbase