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
Manage cross-functionally to assure aligned approach to inspection readiness strategy with Clinical Quality Assurance (CQA) and Global Development Compliance partners is actioned to study execution teams
Champion inspection readiness process improvements and provide direct change management support for clinical trial delivery projects and initiatives
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, but not limited to, Inspection Readiness Plans, completion of Inspection Readiness Checklist, TMF quality and process adherence, identification & mitigation of inspection risks, storyboard development for high-risk issues, and creation of functional presentations in preparation for mock and actual inspection
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 and manage/action compliance monitoring signals with study execution teams. Provide reporting to senior leadership on key performance indicators and mitigation strategies related to clinical trial inspection readiness including quality TMF documentation
Act as investigation lead for study specific quality events including corrective and preventative action management in partnership with QA and the study execution team
Identify and engage appropriate Sponsor and CRO SMEs in the inspection readiness activities. Actively participate in Strategy Team Meetings and Lead Core Team Meetings for assigned Inspection Readiness projects
Maintain documentation such as project management plans/trackers, timelines, and progress reports to track, manage, and report on study execution teams’ inspection readiness
During inspections, manage functional teams by facilitating request strategies and responses with appropriate functional SMEs; providing necessary follow-up and guidance to ensure timely fulfillment; liaising with functional SMEs and QA to assure alignment; providing regular status updates to appropriate stakeholders and leadership
Contribute to development of and lead assigned 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.
Monitor compliance of TMF deliverables and oversight of resources in the execution of inspection readiness plans.
May serve as TMF subject matter expert for regulatory inspections of Takeda, responsible for ensuring execution of IR strategy and assist with presentation/representation of TMF Process to inspectorate
May participate in management of day-to-day activities of assigned staff providing guidance, coaching and supporting issue escalation to achieve organizational and individual development goals.

Requirements

Minimum of 6+ years clinical research experience in pharmaceutical or biotechnology field
Solid knowledge of and experience in 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 is required
Solid knowledge of regulatory requirements governing clinical trials and industry best practices
Bachelor’s degree preferred or commensurate with experience
Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations.

Benefits

U.S. based employees may be eligible for short-term and/or long-term incentives.
U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

GCPTMF documentationInspection Readiness PlansInspection Readiness Checklistrisk managementproject managementclinical trial processesregulatory inspection readinesscorrective and preventative action managementcompliance monitoring

Soft skills

problem solvingnegotiationscollaborative team buildingleadershipcommunicationchange managementcoachingguidancestakeholder managementprocess improvement