• Provide guidance to Clients on TMF Standard Operating Procedures, processes, best
practices and technology.
• Offer direction and support on TMF training.
• Provide operational excellence through best practices and lesson learned.
Position Title: Trial Master File (TMF) Consultant I/Consultant II/Principal Consultant
Reports to: President and CEO/Vice President of Clinical Operations/Project Leader
Location: Remote/Clients Office
The TMF Consultant may be the single point of contact for the client for all TMF projects. The clinical trial documentation must be consistent with the Trial Master File Specifications, submission/inspection readiness criteria and comply with applicable SOPs and other requirements, The TMF Consultant may provide guidance to support how to obtain consistency through the use and application of standards. The TMF Consultant will act as a TMF subject matter expert, applicable technologies, and processes. Provide complete TMF services for custom development, and business process outsourcing for Clients. Develop the post implementation go-live support environment, construct the transition plan from the project team to the support team, and support and maintain the client applications and technology infrastructure. There are three tiers of Consultants reflecting increasing experience and responsibility with increasing level.
This is a one-year contract with the possibility of an extension and the desired candidate MUST have Non-Interventional Study (NIS) experience.