Clinical Operations Manager

6 days ago

🍂 Massachusetts – Remote

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

💵 $99.5k - $156.4k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

🦅 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

• Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan. • In close collaboration with Clinical Operations Program Lead(s): Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget. • Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives.

🎯 Requirements

• BS/BA required, preferably in a health-related, life science area or technology-related fields or equivalent combination of education, training and experience. • Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship, internships, etc.) may be considered to supplement experience requirements. • 5 or more years’ experience in pharmaceutical industry and/or clinical research organization, including 3 or more years clinical study management/oversight, including significant study management support experience (e.g., clinical trial assistant/associate or lead CRA). • Experience could include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. • Experience in more than one therapeutic area is advantageous. • Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. • Awareness of local country requirements is also required. • Demonstrated successful experience in project/program management and matrix leadership. • Good communication skills. • Excellent teamwork, organizational, interpersonal, and problem-solving skills. • Fluent business English (oral and written).

🏖️ 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.