Gary M. Email & Phone Number

• Develop and maintain internal data repositories for storage of departmental level information
• Collaborates with trial execution teams on proper use of repositories and e-TMF systems
• Lead TMF educational workshops and trainings
• Develop and maintain trial master file SOP’s and work processes
• Serve as e-TMF administrator and interface with e-TMF vendor on system configuration
• Lead e-TMF implementation activities

Cambridge, MA

• Establish document standards, requirements, process and reports that allow for the collection and maintenance of trial documents while the study is ongoing.
• Participate in the creation of the Akebia Trial Master File plan for each study, creating a template and standard content.
• Establish or approve standards, requirements, processes and reports to be used when a contract research organization is managing the Trial Master File.
• Develop study specific eTMF plans and lead system set-up.
• Adheres to standards and processes in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Manage and lead a team of document managers and archivists (including vendors).

Cambridge, MA

 Collaborate with internal departments on implementation of quality principles and regulatory requirements related to Good Pharmacovigilance Practice (GVP) Assist with the QC and file review of SABR TMF documentation Coordinate document workflow and ensure the appropriate review and approval of all SABR controlled documents worldwide. Authors and/or.

General Archival DutiesProvide training for temporary archival employees, new Vertex staff and for new procedures and processes for all staffCoordinate access to the clinical study documents needed by Business Development or Legal for out-licensing projects or due diligenceCoordinate access to study documents for internal or external audits or.

Responsible for all clinical trial documentation in a GCP environment. Auditing of central files to ensure that all regulatory documents correspond with the regulatory documents at investigators' sites.Ensure the completeness of records, that all protocols, consent forms, data management and biostats documents are properly filed. Manage and work closely.