TMF Specialist
On-siteSavannah, Georgia, United States
Job Summary
Oversee the management and quality of essential clinical trial documents to ensure audit and inspection readiness by working with multi-functional study teams and vendors to maintain TMFs in both electronic and paper formats. Maintain the study-specific TMF Management Plan and perform quality control on documents to ensure high quality per data quality standards and specified system guidelines. Manage the conduct of TMF quality reviews by the cross-functional study team, driving closure on findings, and support functional owners in identifying and managing the collection of study-specific TMF content from both sponsor and CRO sources. Assess outstanding issues and follow through to resolution while following international good clinical practice guidelines and standard operating procedures. Daily interaction with the clinical team, project managers, and cross-functional members includes planning and executing study-specific meetings. Requires a Bachelor's Degree, 3-5 years of TMF management experience, working knowledge of VEEVA Vault, and strong FDA & ICH/GCP regulations knowledge.
Required Qualifications
- Bachelor's Degree
- 3-5 years of experience working in pharmaceutical/biotechnology or CRO organization in TMF management
- Working knowledge of VEEVA Vault
- Strong working knowledge of FDA & ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures
- Proficient in computer technology used in an office environment (Microsoft Word, Excel, and PowerPoint) and Share point
- Exceptional attention to detail
- Ability to work independently and collaboratively with excellent written communication, oral communication, and organizational skills
- Current authorization to work in the US
Desired Qualifications
- Strong interest in clinical trials and initiative to learn and participate in projects of increasing responsibility
- Highly responsive and proactive, a team player
- Excellent communication and organizational skills and the ability to work effectively in a high-paced, fast changing environment
- Flexible attitude with respect to work assignments and new learning
- Conscientious, influential person with an outstanding work ethic and strong personal discipline
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