TMF Lead II

Premier Research is seeking a TMF Lead II to join the Pharmacovigilance and Records Management team, responsible for managing electronic and paper Trial Master File records in compliance with industry and regulatory standards. The role involves leading the setup, maintenance, and closure of TMFs, providing oversight and training to ensure project compliance, and addressing quality deficiencies to maintain audit readiness. This position serves as the primary point of contact for project teams, sponsors, and auditors while coordinating quality reviews and participating in TMF audits and inspections.