Manager, GCP Excellence in Clinical Trials

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

GOALS:

• Manage and facilitate cross-functional study execution teams’ efforts towards proactive GCP inspection readiness, focusing on process adherence, TMF documentation, inspection preparation and inspection execution activities, including collaboration with CRO partners.
• Work in alignment with Clinical Quality Assurance (CQA) and Global Development Compliance partners to assure approach to inspection readiness strategy is actioned to study execution teams
• Support the implementation of inspection readiness process improvements and assist with change management for clinical trial delivery projects and initiatives.
• Coordinate TMF inspection readiness and oversight strategies with study execution teams in alignment with GCP Excellence in Clinical Trials leadership.

ACCOUNTABILITIES:

• Provide support in 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.
• Assist study execution teams in prioritizing process adherence, inspection readiness deliverables and mitigation of inspection risks in real time throughout the study lifecycle.
• Guide study teams on adherence to ways of working and well-maintained study documentation and action compliance monitoring signals with study execution teams.
• Report to senior leadership on key performance indicators related to clinical trial inspection readiness and TMF documentation quality.
• Coordinate with appropriate Sponsor and CRO subject matter experts in inspection readiness activities and actively lead/participate in Strategy Team Meetings 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, assist in management of 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 departmental objectives, representing GCP Excellence globally, assisting in  implementing GCP Excellence processes to enhance support and compliance.
• Act as subject matter expert for operating model and TMF processes, supporting 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 manage day to day activities of assigned staff providing guidance, coaching and supporting issue escalation to achieve organizational and individual development goals.

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EDUCATION AND EXPERIENCE:

• Bachelor’s degree preferred or commensurate with experience.
• 5 or more years clinical research experience in pharmaceutical or biotechnology field required.
• Knowledge of and experience in regulatory inspection readiness and execution processes.
• Experience with Sponsors, 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.
• Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 

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.