• To provide internal and external teams with outstanding TMF operational expertise and ensure deliverables with quality, on time, and cost-effective with measurable services.
• To develop strong values and foster innovations in TMF process.
• To continuously improve performance and productivity (ensure high skill level), and provide operational excellence through best practices and lesson learned.
Position Title: Trial Master File (TMF) Support Analyst I/ Support Analyst II/Senior Support Analyst
Reports to: President and CEO/Vice President of Clinical Operations/Project Leader/Project Manager/TMF Support Analyst Manager
Location: Remote/Clients Office
The Trial Master File (TMF) Support Analyst is the Quality Control Expert and will ensure TMF and documents accuracy and completeness. The clinical trial documentation must be consistent with the Trial Master File Specifications, submission/inspection readiness criteria and comply with LMKs (or clients) SOPs and regulatory requirements. The TMF Support Analyst is to serve as single point of contact to the TMF Project Manager or equivalent to ensure a complete and accurate TMF through documentation quality and consistency across clinical trials and programs. The TMF Support Analyst may also serve as a subject matter expert in TherAlign commissioned projects. There are three tiers of TMF Support Analysts reflecting increasing experience and responsibility with increasing level.