The Senior TMF Specialist is responsible for collecting, reviewing, and archiving essential regulatory documents to ensure the Trial Master File remains current and inspection-ready. They will act as a subject matter expert, collaborating with study teams and CROs to manage document quality and resolve gaps in the eTMF.
The Senior Manager will lead and execute qualification and validation activities for GxP-regulated computerized systems and IT infrastructure throughout their lifecycle. They will also manage contract CSV resources and collaborate with cross-functional teams to ensure ongoing regulatory compliance and inspection readiness.
The Clinical Trial Manager oversees the operational aspects of clinical studies, including vendor management, site oversight, and adherence to regulatory guidelines. They are responsible for managing project timelines, budgets, and cross-functional team coordination to ensure successful trial delivery.
