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• Ensures quality checks of TMF content and accuracy of coding are performed• Addresses TMF questions pertaining to document workflows and user questions related to the TMF system• Provide TMF status reports at study team meetings• Manage TMF room entry logs, document check in/check out logs, access and temperature logs• Coordinate the long-term storage archival of original documents and maintain document integrity per mandatory retention policies• Monitor and identify study specific TMF trends

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).• Ensure training of internal and external team members on appropriate SOPs and processes and effective training of assigned clinical studies.• Responsible for up to date TMF information within relevant tracking systems and provide management with routine updates regarding the status of ongoing studies.• Proactively identify and resolve issues and manage escalation as appropriate.• Utilize appropriate systems and standard processes to ensure quality and consistency of operational activities across studies and indications.• Participate in clinical trial team meetings, vendor meetings and contract research organization where applicable

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 edits SABR procedural documents. Ensures proper grammar, format, and clarity. Oversee the administrative/technical aspects of SABR procedural documents. Responsible for the drug safety documentation archiving in accordance with corporate records management policies and archive room maintenance Assist with implementing tracking and filing process for managing the SABR Secure file room documentation

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 inspectionsAssist other functional departments with developing and maintaining their own files and documentsBackup GLP ArchivistSupport customer requests for records in a timely and cost effective manner Carry out complex searches across various Vertex systems to ensure retrieval of complete and accurate information as appropriate for customer requestsSupports cross-functional project teams managing budgets to deliver technical and operational solutions to implement process improvementsLiaise with Subject Matter Experts across Vertex to identify the required information based on project specificationsSupports IRM record management processes as applied to business records generated during the drug development process Track and report progress on ongoing projects to customers and IRM managementElectronic Document and Record Management Scanning of paper documentsLoading of electronic files into appropriate location within vDoCC including coordination with clinical and scientific staffEntry of metadata into appropriate fields in OmniRim and vDoCCStandardization of controlled vocabulary including picklists, field names and Vertex thesauriCoordination with Regulated Systems and IT staff for effective utilization of electronic resourcesGxP Document ManagementMaintain current knowledge of and implement good records management practices in accordance with applicable regulationsParticipate in internal and external training and networking opportunities relevant to content and record management, and regulatory guidance's

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 with all departments in the archiving of all study documents at the completion of trial. Including the retrieval, addition and destruction of files within the inventory. Work closely with Project Managers during study start-up to verify that all study related documents are being filed according to the sponsors requests and SOPs. Responsible for the training of Central Files staff to ensure that quality standards are being met. Restructured operations in the department for filing, tracking the status of open studies, and all study related issues, eliminating wasted time and resources, maximizing use of space, and streamlining the overall processes.Implemented a tracking system by which Central Files tracked document retrieval, review and disposition. Participated in Sponsor audits as the main contact for clinical trial working files.