Clinical Study Manager

Job not on LinkedIn

November 25

🍂 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 Research

🦅 H1B Visa Sponsor

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Takeda

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Biotechnology • Pharmaceuticals • Healthcare Insurance

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.

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). • 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. • Provide subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents. • Challenges study team to ensure operational feasibility, inclusive of patient and site burden. • Validates budget and ensures impacts are adequately addressed. • Participates in country and site feasibility/selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy. • Ensure new team members and vendors are appropriately onboarded. • Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly. • Responsible for study budget planning and management and accountable for external spend related to study execution.

🎯 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). • Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. • Good communication skills. • Fluent business English (oral and written).

🏖️ Benefits

• 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 • up to 80 hours of sick time • up to 120 hours of paid vacation