A Phamaceutical company is hiring for a TMF operations specialist.
This person will be responsible for the maintenance, quality review, transfer, closure and archival of Sponsor Trial Master File (TMF) essential documentation in accordance with regulatory requirements and principles and standards of Good Clinical Practice (GCP) International Conference on Harmonization Regulations (ICH) E6 (R3), and European Union (EU) regulations/directives, and Standard Operating Procedures (SOPs) as appropriate. The TMF Operations Specialist will provide support to the TMF content owners on one or more clinical programs. This position serves as a pivotal point of contact and works closely with internal Study Management Teams (SMTs) and external CROs/Vendors to ensure that the TMF is complete, accurate, contemporaneous, and inspection ready according to TMF SOPs and TMF Plans.
Requirements :
1. This position is remote based, but candidates must reside within the North Bay Region of California area for ad-hoc on-site visits to the CA office for receipt, inventory review, and storage of TMF Final Transfers.
2. Bachelor’s degree or equivalent curriculum (scientific or healthcare discipline preferred) and a minimum of 2 years of professional TMF document control experience. People without a formal degree who have a minimum of 4 years of training and work experience in document control and who meet job-specific criteria are eligible for consideration.
3. Experience with electronic trial master file systems (Veeva Vault eTMF), workflows, configurations, feature/functionality, and industry best practices for business process alignment
4. Advanced knowledge of ICH/GCP Regulations, GDP and ALCOA+ requirements, CDISC Reference Model, and industry best practices
5. Demonstrated knowledge of Sponsor TMF regulatory requirements and an understanding of the range of working procedures relating to it, together with an understanding of Good Documentation Practices (GDP)
6. Familiarity with international clinical trials, clinical trial documents, and document QC process highly desirable
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