Senior Manager - GCP Excellence in Clinical Trials

April 2

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $137k - $215.3k / year

⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

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Takeda

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Takeda is a global biopharmaceutical company dedicated to bringing better health and a brighter future to patients worldwide. With a strong focus on research and development, manufacturing, and quality, Takeda operates with a commitment to ethics and a diverse workforce that spans over 80 countries. The company leverages innovative science and partnerships to create impactful medicines, including therapies in oncology and vaccines, ensuring that they effectively meet the needs of the patients they serve.

Pharmaceuticals • Therapeutics • Oncology • Gastroenterology • Vaccines

10,000+ employees

Founded 1781

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Grant on 2016-08

📋 Description

• Project manage and facilitate cross-functional study execution teams’ GCP inspection readiness and inspection activities. • 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. • Provide project management, oversight, and expert GCP guidance to study execution teams in Inspection Readiness. • 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. • During inspections, manage functional teams by facilitating request strategies and responses with appropriate functional SMEs. • Contribute to development of and lead assigned departmental objectives.

🎯 Requirements

• Bachelor's degree preferred or commensurate with experience. • 6 or more years clinical research experience in pharmaceutical or biotechnology field required. • Problem solving, negotiations and collaborative team building with non-direct reports and other stakeholders is required. • 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. • 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.

🏖️ Benefits

• Eligible for short-term and/or long-term incentives. • Eligible for medical, dental, vision insurance. • 401(k) plan and company match. • Short-term and long-term disability coverage. • Basic life insurance. • Tuition reimbursement program. • Paid volunteer time off. • Company holidays. • Well-being benefits. • Eligible to receive up to 80 hours of sick time per calendar year. • Eligible to accrue up to 120 hours of paid vacation per calendar year.