Sr Manager, GCP Excellence in Clinical Trials

Role Summary

Sr Manager, GCP Excellence in Clinical Trials – Location: Massachusetts (Virtual). This role is responsible for leading cross-functional study execution teams through GCP inspection readiness and inspection activities, maintaining TMF documentation, and coordinating with Clinical Quality Assurance and Global Development Compliance to support audits and inspections. The role champions process improvements, drives change management for clinical trial delivery, and collaborates to ensure aligned inspection readiness strategies across study teams.

Responsibilities

• Project manage and facilitate cross-functional study execution teams’ GCP inspection readiness and inspection activities, including strategies to support process adherence, well-maintained TMF documentation and proactive study team preparedness for audits and inspections.
• Coordinate and manage TMF process and inspection readiness strategies in collaboration with study execution teams and GCP Excellence in Clinical Trials leadership.
• Provide project management, oversight, and expert GCP guidance to study execution teams in Inspection Readiness, including Inspection Readiness Plans, Completion of Inspection Readiness Checklist, TMF quality and process adherence, risk identification & mitigation, and preparation for mock and actual inspections.
• Manage study execution teams in prioritizing process adherence, inspection readiness deliverables, and mitigation of inspection risks throughout the study lifecycle.
• Lead and guide study teams on adherence to ways of working and associated documentation and deliverables.
• Collaborate cross-functionally to manage compliance monitoring signals with study execution teams and provide reporting to senior leadership on KPIs and mitigation strategies related to clinical trial inspection readiness, including TMF quality documentation.
• Act as investigation lead for study-specific quality events, including CAPA management in partnership with QA and the study execution team.
• Identify and engage Sponsor and CRO SMEs in inspection readiness activities; participate in Strategy Team Meetings and Lead Core Team Meetings for assigned projects.
• Maintain documentation such as project management plans/trackers, timelines, and progress reports to track and report on study execution teams’ inspection readiness.
• During inspections, manage functional teams by facilitating request strategies and responses with SMEs; provide follow-up and guidance to ensure timely fulfillment; liaise with SMEs and QA to ensure alignment; provide regular status updates to stakeholders and leadership.
• Contribute to development of departmental objectives, representing GCP Excellence globally; develop and implement GCP Excellence processes to enhance support and compliance, identifying areas for improvement.
• Manage study-execution teams in development of risk-based TMF oversight strategies and monitor compliance of TMF deliverables and resources.
• May serve as TMF subject matter expert for regulatory inspections of Takeda, responsible for ensuring execution of IR strategy and assisting with TMF Process presentations to inspectors.
• May participate in managing day-to-day activities of assigned staff, providing guidance and coaching to achieve development goals.

Qualifications

• Minimum of 6+ years clinical research experience in pharmaceutical or biotechnology field.
• Solid knowledge of regulatory inspection readiness and execution processes.
• Experience with CROs and outsourced clinical trial activities.
• Solid knowledge of drug development and clinical trial processes, including related standards and documents.
• Experience in problem solving, negotiations and collaborative team building with non-direct reports and other stakeholders.
• Solid knowledge of regulatory requirements governing clinical trials and industry best practices.

Education

• Bachelor’s degree preferred or commensurate with experience.
• Proficiency in computer software programs such as Microsoft Office for general use, project management, and presentations.