Date: Jan 17, 2024
Department: GRD Clinical Development
Job Type: Direct Employee
Team: R&D, Pharmacovigilance & Regulatory Affairs
Contract Type: Permanent
Location:
Boston, US
Main Responsibilities
TMF Management and Reporting: Handles and maintains electronic TMF and electronic internal repository according to ICH/GCP guidelines and applicable regulations/ standards. Responsible for preparing the periodic internal reports on eTMF healthiness and serves as an escalation point for the study team members involved in eTMF management. Liaise with the TMF vendor as required. Supports the study teams on eTMF audit and inspection readiness activities.
Due Diligence: Participates in Due Diligence activities related to TMF. Supports the team on gap analysis/ verification activities on TMFs acquired through acquisition.
Meetings: Organizes the periodic TMF Oversight meeting with the applicable parties. Ensure the required action items are distributed to the study teams and escalated as required.
Purpose
This position will oversee the global eTMF (electronic Trial Master File) operations for GRD R&D including providing support to all study teams members involved in eTMF management. Responsible for creation and revision of all eTMF associated procedures, ensuring they are up to date and compliant with the applicable regulations.
This position will assume the leadership role for global eTMF operation to ensure the quality KPIs are met and eTMFs are inspection ready at all times.

• Global oversight of the eTMFs, ensuring that the study teams are maintaining inspection ready files across all programs.
• Establish KPIs and metrics for documents filed in the eTMF to improve performance, quality, risk mitigation and contingency planning.
• Develop and embed process excellence and consistency across eTMFs management.
• Establish industry standard processes for eTMF by incorporating the applicable changes to the TMF reference model.
• Accountable to ensure consistency in eTMF management at all stages (eTMF set-up, maintenance, QC/ QR and query management, final reconciliation, closure, migration and archiving).
• Provide TMF support for both inspection and audit activities for internal and external hosted audits. This includes working directly with Agency Inspectors (FDA, EMA, PMDA, MHRA, etc) or auditors; assist with retrieving documents, speaking to the TMF process and assisting with resolving potential issues identified.

Education

• BS/BA in Life Sciences or similar discipline

Experience Required

• Minimum 5 years of experience in similar position in Pharmaceutical or CRO industry and in R&D environment
• Demonstrated individual and team leadership skillsExtensive experience managing eTMF including set-up, maintenance, QC/ QR and query management, final reconciliation, migration and archiving.
• Experience with various eTMF systems; must have experience with Phlexglobal eTMF
• Strong knowledge of the TMF reference model
• Experience managing paper TMF is preferred
• Previous experience with internal/ external audits and inspection is an asset
• Knowledge of ICH GCP and applicable regulations
• Strong knowledge of Good Document Practice requirements & ALCOAC standards
• Demonstrated proficiency in written, verbal and face-to-face communication to effectively present information to and influence decision making of managers, working partners (local and global), and government agencies
• Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining high attention to detail and responding to rapidly changing priorities and aggressive deadlines
• Proficient in MS Office (Word, Excel, Outlook, Project and PowerPoint), Adobe and ISI Toolbox

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