Hayley Gastiger
Senior Trial Master File Lead @Syneos Health
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WORK HISTORY
Senior Trial Master File Lead @Syneos Health
Actively involved in risk management/mitigation to ensure a high quality audit-ready TMF. Develops plans to increase compliance and follows up on non-compliance.Attends internal project team and sponsor teleconferences and face-to-face meetings as TMF SME, as applicable, to the project/program.May provide input to Functional Service Provider (FSP) TMF proposals and participate in new business opportunities. Supports TMF Management by contributing to customer solutions/proposals and any associated costing.Designs and/or delivers applicable project-specific TMF training in various formats via teleconference, video conference, and in person. Monitors and reports on TMF Health, including identifying risks, issues and mitigation plans for the project.Prepares and participates in audits/inspections to ensure ongoing inspection-readiness of the TMF.Provides regular feedback to the Project Team on TMF Health/status including actionable metrics for projects/programs. Identifies TMF best practices and leads/participates in TMF process improvement initiatives and the maintenance of the TMF best practices information and any other relevant documentation.Presents monthly TMF status, risks, issues and associated actions for assigned projects during project meetings.Provides timelines to the Project Team and TMF Operations Team for the TMF transfer, including timelines for final Completeness Checks, document submissions, TMF Export and QC and transfer to the client.Ensures a thorough understanding of contracted scope, timeline, and budget for the TMF. Works with department management to monitor TMF team performance to the budget and communicates any out-of-scope work to the Project Lead to add to a Change Notification Form/Change Order, as required.Mentors and provides training to TMF Leads on all TMF Lead responsibilities.Develops and enhances training material applicable to TMF Lead responsibilities for the department.
EDUCATION
University of North Carolina Wilmington
Bachelor's Degree, Clinical Research
SKILLS
ABOUT HAYLEY GASTIGER
Trial Master File Lead at Syneos Health (Previously INC Research/inVentiv Health)
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