Clinical Study Associate Manager

Regeneron Pharmaceuticals

2d • $112,100 - $182,900 • Onsite

About The Position

Regeneron is seeking a Clinical Study Associate Manager to join its Clinical Trial Management team. The role supports the Clinical Study Lead and takes responsibility for areas of clinical trial delivery, including studies managed internally and those outsourced to CROs. The position collaborates with internal study teams and external vendors. It may lead or oversee planning and management of a clinical study in assigned regions, contribute to global study planning, and oversee study execution, documentation, vendors, recruitment, data quality, budgets, compliance readiness, and close-out activities. The role may also mentor clinical trial management staff and may be assigned unmasked study tasks. Locations are Armonk, New York; Warren, New Jersey; or Cambridge, Massachusetts. Travel may be required up to 25%. The position is expected to be performed onsite for many roles; specific onsite expectations should be confirmed with the recruiter and hiring manager.

Requirements

• Bachelor's degree and 4 or more years of relevant industry experience.
• Data-driven approach to execution and problem-solving, with attention to detail and the ability to deliver specific study activities.
• Technical proficiency with trial management systems and Microsoft applications, including Project, PowerPoint, Word, and Excel, as well as IVRS/IWRS, EDC, and TMF.
• Budget awareness and ability to participate in budget management.
• Familiarity with medical terminology.
• Vendor management experience.
• Clinical trial operations experience, including experience developing key study documents.
• Knowledge of ICH/GCP and regulatory guidelines and directives.

Responsibilities

• May lead or oversee clinical study planning and management in assigned regions in alignment with global study plans, and may contribute to global study planning and management.
• Contribute to risk assessment, identify risk mitigation strategies, and support feasibility assessments to select regions and countries.
• Oversee and provide input to study-specific documentation, including case report forms, data management plans, monitoring plans, and monitoring oversight plans; review site-level informed consents and other patient-facing start-up materials.
• Oversee setup and maintenance of study systems, including CTMS and TMF, and contribute to investigator meeting preparation and execution.
• Oversee engagement, contracting, and management of study vendors.
• Oversee and provide input to 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 recruitment and retention strategy development and oversee implementation; monitor recruitment, retention, site activation, and monitoring visit progress.
• Support data quality through regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected site non-compliance; escalate data flow and data quality issues to the Clinical Study Lead.
• Oversee study deliverables against planned timelines, escalate timeline or budget issues to the Clinical Study Lead, and support accurate budget management and scope changes.
• Contribute to audit and inspection readiness throughout the study lifecycle; support internal and external inspections and contribute to CAPAs as required.
• Manage aspects of study close-out, including database lock and reconciliation of vendor contracts, study budget, TMF, and study drug accountability.
• May mentor clinical trial management staff.
• May undertake assigned unmasked study tasks, such as unmasked TMF management, unmasked data review, or serving as the IVRS point of contact.

Benefits

• Competitive and comprehensive total rewards package, which may include 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, paid time off, and family support benefits. Availability depends on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level