Clinical Study Associate Manager

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Join our Clinical Trial Management team as a Clinical Study Associate Manager and support the Clinical Study Lead in delivering clinical trials, both internally sourced and outsourced to CROs. Collaborate with internal study teams and external vendors to make a meaningful difference for patients worldwide.

About the Role

• May lead or oversee the planning and management of a clinical study in assigned region(s) in alignment with global study plans, and contribute to global planning and management.
• Contribute to risk assessment, identify risk mitigation strategies, and support feasibility assessments to select relevant regions and countries.
• Oversee and provide input on the development of study-specific documentation (e.g., CRF, data management plan, monitoring plan, monitoring oversight plan) and review site-level informed consents and other patient-facing study start-up materials.
• Oversee the setup and maintenance of study systems, including CTMS and TMF, and contribute to investigator meeting preparation and execution.
• Oversee engagement, contracting, and management of required vendors for the study.
• Oversee and provide input on study drug and clinical supplies forecasting, drug accountability, and reconciliation.
• Provide regular status reports to collaborators as requested by the Clinical Study Lead.
• Contribute to and oversee the implementation of recruitment and retention strategies.
• Monitor recruitment, retention, site activation, and monitoring visits progress.
• Support data quality by reviewing data metrics, listings, protocol deviations, eligibility violations, dosing deviations, and suspected site non-compliance; escalate data flow and quality issues to the Clinical Study Lead.
• Oversee execution of clinical study deliverables against planned timelines, escalate timeline or budget issues, and support accurate budget management and scope changes.
• Contribute to clinical project audit and inspection readiness throughout the study lifecycle, support internal and external inspection activities, and contribute to CAPAs as required.
• Manage aspects of study close-out activities, including database lock, reconciliation of vendor contracts, study budget, TMF, and study drug accountability.
• May mentor clinical trial management staff and be assigned unmasked tasks for studies (e.g., unmasked TMF management, unmasked data review, IVRS point of contact).

Requirements

• Bachelor’s degree and 4+ years of relevant industry experience.
• Excellent communication and interpersonal skills; ability to build relationships internally and externally.
• Data-driven approach to executing and problem-solving, with strong attention to detail for delivering specific study activities.
• Technical proficiency in trial management systems and MS applications (e.g., Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF).
• Budget awareness and ability to participate in various aspects of budget management.
• Familiarity with medical terminology and vendor management experience.
• Experience in clinical trial operations, including developing key study documents.
• Knowledge of ICH/GCP and regulatory guidelines/directives.

Location

Armonk, NY or Warren, NJ. This role may require up to 25% travel.

Pay

Salary Range (annually): $109,900.00 - $179,300.00.

Benefits

Regeneron offers a competitive and comprehensive total rewards package, which may include:

• Annual bonuses or other incentive plans.
• Equity awards.
• Pension or retirement benefits (e.g., 401(k) company match).
• Health and wellness programs, including fitness centers.
• Insurance benefits (e.g., medical, dental, vision, life, and disability).
• Paid time off and family support benefits.

For additional details about Regeneron benefits in the U.S., visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, information will be provided during the recruitment process.