Senior Clinical Trial Manager

2 days ago

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Immunovant

WebsiteLinkedInAll Job Openings

Biotechnology Research

51 - 200 employees

Founded 2018

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Description

• Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. • The Senior Clinical Trial Manager will support the advancement of rare disease clinical trials as part of Immunovant's Clinical Operations Team. • Key responsibilities include leading study start-up activities, maintaining studies, and closing-out studies.

Requirements

• BA/BS in clinical or scientific discipline, at least 8 years experience with clinical trials; working with a Sponsor company • Must have at least 3 years of project management experience • Required Phase II / Phase III clinical trial management experience • CRO experience preferred • Required experience managing all aspects of clinical trials from start-up, maintenance, through closeout • Required experience with managing and coordinating multiple workstreams, both internal and external, such as: • EDC • IWR • eCOA • Clinical Drug Supply • Risk-based monitoring • Pharmacovigilance • Labs • Clinical monitoring • Strong knowledge of ICH/GCP guidelines and multinational clinical trial regulations, as well as cross-functional clinical processes, including clinical supply, data management, biostatistics, medical writing, drug safety, regulatory affairs, and legal considerations. • Deep understanding of clinical trial operations and management of clinical trials at investigator sites • Multitasking ability to oversee many projects and reach milestones on time • Exceptional academic and professional accomplishments, indicating critical thinking ability • Strong written and oral communication skills with incredible attention to detail • Ability to think outside of the box and challenge the status quo • Natural entrepreneurial spirit with unrelenting dedication to delivering results • Desire to work in a fast-paced, innovative environment • Natural collaborator who enjoys working on a cross-functional team

Benefits

• Full range of medical, dental, vision, 401k • Unlimited paid time off • Parental leave