Provides oversight of all electronic and/or paper Trial Master File (TMF) management activities for assigned projects from award to final transfer. Drives and oversees successful completion of all TMF scoped deliverables including TMF Plan development, TMF set-up, monitoring document submissions/publishing and processing, oversight and coordination of Quality Control (QC) processes, internal and external audit representation, TMF shipments, etc. Involved in monthly project reviews evaluating operational and financial Key Performance Indicators.
• Attends Trusted Process meetings such as Kick-Off, QuickStart Camps, Jump Start Camps, Quality Finish Camps, etc. as TMF Subject Matter Expert (SME) and successfully communicates and presents TMF status updates and seeks relevant information to drive the execution/delivery of the TMF.
• Evaluates and provides recommendations on optimal TMF set-up. Drives the TMF set-up, structure, and completeness reports.
• Actively involved in Collaborative Workspace including set-up and training for the internal or external team members, as applicable.
• Collaborates with the Project Lead (PL) and Functional Leads (FL) to ensure TMF documentation is submitted/published in a timely manner and with high quality in order to maintain the TMF in an audit-ready state. Develops plans to increase compliance and follows up on non-compliance, if applicable.
• Attends internal project team and sponsor teleconferences and face-to-face meetings as TMF SME as applicable to the project.
• Designs and/or delivers study specific TMF training in various formats via teleconference, video conference, and/or in person.
• Generates and provides Completeness Reports to the Project Team
• Prepares and participates in audits/inspections to ensure ongoing readiness of the TMF.
• Provides regular feedback to the Project Team on TMF health/status, including actionable metrics. As necessary,provides re-training to the Project Team.
• Represents the TMF during Quality Finish Meetings, provides guidance to the Project Team and TMF Operations Team on perfoming the final QC/Completeness Review, and oversees the TMF Shipment.
• Ensures thorough understanding of contracted scope, timeline, and budget for the TMF. Works with department management to monitor TMF team performance to the budget and documents any out-of-scope work in Change Notification Form/Change Orders as required.
• Presents monthly TMF status, risks, issues and associated actions for assigned projects during the Project Review Meeting (PRM).
• Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
Undergraduate degree and moderate experience in a Contract Research Organization or related field. Experience with leading/co-leading studies from award into maintenance through close-out on a global scale. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills. Ability to perform several tasks simultaneously to meet deadlines. #LI-JP1