What are the responsibilities and job description for the TMF Specialist position at Actalent?
Hybrid TMF Specialist
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
Qualifications
Must have a minimum of 1 year relevant clinical research and TMF experience at a biotechnology, pharmaceutical company or CRO
Must have experience working in eTMF system software OR Veeva Vault
Strong knowledge of ICH-GCP guidelines and regulatory requirements related to clinical document management
Minimum B.A./B.S. degree in science/healthcare field required
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
