Manager, Trial Master File (TMF) Operations

The Role: The Manager, TMF Operations will support the implementation of Deciphera’s TMF operational strategy, TMF processes, and TMF services by collaborating with and supporting external and internal team members to ensure an inspection-ready TMFWhat You Will Do:Implements and ensures compliance with all TMF controlled procedural documents (i.e., SOPs, Work Instructions, Templates, and Forms).Supports cross-functional trial teams with TMF processes, TMF plans, and TMF filing.Ensures TMF completeness metrics are met.Assist study teams in preparation for TMF audits and TMF regulatory inspections.May support TMF process improvement initiatives to increase departmental TMF execution and effectiveness.Tracks and trends TMF KPIs, metrics, and overall completeness.Documents, communicates, and escalates risks to Line Manager and Clinical Operations, and applicable.Demonstrates excitement around the Vison and Mission of Deciphera and the departmentOther duties as assigned