TMF Specialist

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 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

Requirements

• 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

Education

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

Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.

Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals.To learn more, please visit https://dexian.com/.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.