Job DescriptionThe TMF Specialist is responsible for overseeing the overall management and quality of essential clinical trial documents to ensure compliance with applicable regulatory and local requirements. This position will provide management and oversight of Trial Master File (TMF) filing activities to ensure audit and inspection readiness for clinical trials.
Responsibilities:- Works with multi-functional study teams and vendors to ensure the maintenance of TMFs, both electronic and paper, in a state of inspection readiness.
- Maintains study-specific TMF Management Plan.
- Performing QC on TMF documents to ensure high quality per data quality standards and specified system guidelines
- Manages conduct of TMF quality reviews by cross-functional study team; driving to closure quality review findings.
- Supports the functional owners in the identification and management of the collection of study specific TMF content, (both sponsor and CRO).
- Assessing outstanding issues and following through to resolution
- Daily interaction with Clinical team, clinical project managers and members of the cross-functional study team.
- Plan, execute, and lead study-specific meetings.
- Follow international good clinical practice guidelines/regulations and standard operating procedures for executing clinical studies.
- Supports other trial-related operational activities as needed and assigned
Requirements
- Bachelor's Degree Required
- 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 are required
- 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
- Current authorization to work in the US
BenefitsDental, Medical, Vision and 401K