Associate Manager, Clinical Laboratory Study Management

🔥 7 minutes ago

🏖️ New Jersey, New York – Remote

🏖️ New Jersey – Remote 🗽 New York – Remote

💵 $98.1k - $160.1k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Regeneron

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1988

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 Post-IPO Equity on 2023-10

Healthcare • Manufacturing • Biotechnology

Regeneron is a biotechnology company dedicated to turning scientific discoveries into life-changing medicines. The company focuses on a range of serious diseases including allergic, cardiovascular, and metabolic diseases, neuroscience, oncology, hematology, ophthalmology, and rare diseases. It achieves this by integrating biology and technology to develop cutting-edge biologics and genetic medicines. Regeneron is committed to health equity, environmental sustainability, and supporting future STEM talent through initiatives like the Regeneron Science Talent Search. By maintaining high ethical standards and corporate responsibility, Regeneron aims to push the boundaries of science for better healthcare solutions.

📋 Description

• Lead and support Clinical Laboratory Study Managers and external functional service provider resources across assigned therapeutic programs and studies • Partner with clinical study teams, precision medicine leaders, laboratory vendors, CROs, and internal stakeholders to execute sample collection, testing, and data delivery strategies • Oversee operational planning and lifecycle activities for central and specialty laboratory services, including study start-up, execution, and close-out • Monitor clinical sample acquisition and handling activities, ensuring compliance with informed consent requirements and protocol-defined procedures • Provide subject matter expertise on laboratory operations, biospecimen management, and sample-related clinical trial processes • Support vendor selection activities through RFP development, bid evaluations, and scope of work assessments • Collaborate with data management and sample logistics teams to establish processes for laboratory data capture, transfer, blinding, and reporting • Identify operational risks, resolve sample-related issues, and help ensure critical study milestones and laboratory deliverables are achieved on schedule

🎯 Requirements

• Bachelor's degree required • Minimum 6-8 years of pharmaceutical, biotechnology, academic, or governmental cross-functional experience required • Minimum 5 years of clinical trial experience with a focus on clinical sample collection • Extensive experience in clinical laboratory operations, biospecimen logistics, and/or clinical study management • Strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery • Demonstrated knowledge of clinical research, scientific principles, and emerging technologies supporting clinical studies • Proven ability to manage stakeholders, lead internal and external meetings, and develop practical solutions to complex operational challenges

🏖️ Benefits

• Annual bonuses or other incentive plans • Equity awards • Pension or retirement benefits • 401(k) company match • Health and wellness programs • Fitness centers • Medical, dental, vision, life, and disability insurance benefits • Paid time off • Family support benefits • Reasonable accommodation during the recruitment process where required