Gavin Birch Email & Phone Number

Aylesbury, Gb

Aylesbury, Gb

United Kingdom

TMF Specialist subject matter expert, attends Trusted Process meetings such as Kick-Off, Quick Start camps, Quality Finish Camps and successfully monitors and communicates current TMF status for all stakeholders. Leads on the TMF set-up, structure and configures completeness reports on a project/sponsor level, working to develop expected document lists and gap analysis for TMF.

Buckinghamshire, England, United Kingdom

Complimentary working with Jnj UK HQ in High Wycombe, essential functions included study set up and full TMF support from set up for the duration of the trial to archiving.

Camberley, England, United Kingdom

CTA_TMF specialist role identical to above

Marlow, England, United Kingdom

Complimentary working with Allegan, Marlow site - Aligning maintenance, accuracy and completeness of paper /electronic TMF files including study set up / closure and archiving. Support and advise EU based CRA's, oversee audit preparations and provide relevant training to clinical operations staff as required. Assist in development of records management practices, policies and maintain compliance with corporate, legal and regulatory requirements. Represent the TMF Document MgmT and Archiving interests during inter-organizationl meetings and functional teams.

Amersham, England, United Kingdom

Track, Receipt and Process all multi- client Trial Master Files with ongoing study documentation to incude query resolution, paper and electronic copy filing, tracking and QC on completed study documentation.