Associate Manager, Clinical Laboratory Study Management

atRegeneronRemoteFull-timeManagerJuniorMid-level$98.1k – $160.1k/year

Posted Oct 6

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Direct and assist Clinical Laboratory Study Managers along with external functional service provider resources throughout assigned therapeutic programs and studies.

• Collaborate with clinical study teams, precision medicine leaders, laboratory vendors, CROs, and internal stakeholders to implement sample collection, testing, and data delivery strategies.

• Oversee the operational planning and lifecycle activities for central and specialty laboratory services, which include study initiation, implementation, and closure.

• Supervise clinical sample acquisition and handling processes, ensuring adherence to informed consent requirements and protocol-defined procedures.

• Offer subject matter expertise regarding laboratory operations, biospecimen management, and sample-related processes in clinical trials.

• Assist in vendor selection processes by developing RFPs, evaluating bids, and assessing scopes of work.

• Work in tandem with data management and sample logistics teams to set up processes for laboratory data capture, transfer, blinding, and reporting.

• Identify operational risks, address sample-related challenges, and ensure that critical study milestones and laboratory deliverables are met on time.


⛳️ Requirements

• A Bachelor’s degree is mandatory.

• At least 6-8 years of cross-functional experience in pharmaceuticals, biotechnology, academia, or government is required.

• A minimum of 5 years of clinical trial experience focusing on clinical sample collection is essential.

• Extensive experience in clinical laboratory operations, biospecimen logistics, and/or management of clinical studies is necessary.

• Strong comprehension of the technical, clinical, and strategic elements involved in laboratory operations delivery.

• Demonstrated knowledge of clinical research, scientific principles, and emerging technologies that support clinical studies.

• Proven capability to manage stakeholders effectively, lead both internal and external meetings, and devise practical solutions for complex operational issues.


🏝️ Benefits

• Annual bonuses or other incentive plans.

• Equity awards.

• Pension or retirement benefits.

• 401(k) company match.

• Health and wellness programs.

• Access to fitness centers.

• Medical, dental, vision, life, and disability insurance benefits.

• Paid time off.

• Family support benefits.

• Reasonable accommodation during the recruitment process where required.

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