Barry Milne
@barrymilne
Experienced TMF and clinical project specialist delivering accurate trial master file support.
United KingdomWhat I'm looking for
I’m an experienced Project Coordinator, Project Specialist, and Senior TMF Representative who provides highly organised, proactive support to management teams with differing expectations. I enjoy working with highly motivated groups to ensure timely delivery of a final product.
In my Senior TMF Representative role (May 2023 – October 2025), I’ve delivered Trial Master File (TMF) preparation and completeness for internal and external studies. I communicate directly with Sponsors, Project Managers, monitors, sites, and other study contacts to ensure timely receipt of TMF records.
Previously at Syneos Health (October 2019 – March 2023), I served as Trial Master File Lead, overseeing electronic and/or paper TMF management from award to final transfer. I drove TMF-scoped deliverables including TMF Plan development, set-up, document monitoring/publishing, Quality Control (QC) oversight, audit representation, and TMF shipments, while reviewing operational and financial Key Performance Indicators.
Before that, I built deep CRO experience at Quintiles Laboratories (Jul 2010 – Jul 2015) as a Senior Project Coordinator, supporting protocol tasks across project phases and maintaining project documentation and internal databases. I’m especially strong in document management and training/mentoring, and I’m currently seeking a new challenge where I can continue delivering consistent, compliant TMF and project support.
Experience
Work history, roles, and key accomplishments
Prepared and ensured completeness of Trial Master Files (TMFs) for internal and external studies and client-specific specifications. Coordinated TMF document receipt, maintained TMF indexes and electronic file structures, and collaborated with sponsors on TMF plans.
Oversaw electronic and/or paper TMF management activities for assigned projects from award to final transfer. Drove TMF scoped deliverables including TMF plan development, TMF set-up, document submission/publishing oversight, QC oversight, audit representation, and TMF shipments.
Performed project administration across study systems and databases, including KPI status tracking, regulatory document handling, archiving, and preparation of status and financial reports. Coordinated communications, meeting logistics and minutes, audit support, and provided training/mentoring as directed.
Senior Project Coordinator
Quintiles Laboratories
Jul 2010 - Jul 2015 (5 years)
Delivered protocol-specific and routine project tasks supporting all phases of clinical studies. Managed project documentation and internal databases, liaised with other departments and sponsors, supported audits, provided back-up to Project Managers, and contributed to process improvement and training of junior staff.
Education
Degrees, certifications, and relevant coursework
Edinburgh Napier University
Bachelor's degree, Forensic Biology
2006 - 2009
Activities and societies: Hobbies include going to the cinema, spending time with friends, and crafting.
Completed a bachelor's degree in Forensic Biology at Napier University from 2006 to 2009.
Availability
Location
United KingdomAuthorized to work in
Social media
Job categories
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