Clinical Study Associate Manager

Regeneron Pharmaceuticals • Warren, MI

1d • Hybrid

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 across internally sourced and CRO-outsourced studies, collaborating with internal study teams and external vendors. The position is based in Armonk, NY; Warren, NJ; or Cambridge, MA, and is primarily on-site with hybrid flexibility. Travel may be required up to 25%.

Requirements

• Bachelor's degree and 4+ years of relevant industry experience.
• Data-driven approach to execution and problem solving, with attention to detail and ability to deliver specific study activities.
• Technical proficiency in 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 aspects of 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/directives.

Responsibilities

• May lead or oversee planning and management of a clinical study 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 assessment to select regions and countries.
• Oversee and provide input to study-specific documentation, including CRFs, 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 drug 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 execution of 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 inspection activities, 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 be assigned unmasked study tasks, such as unmasked TMF management, unmasked data review, or serving as the IVRS point of contact.

Benefits

• Annual bonuses or other incentive plans may be offered, depending on country and role.
• Equity awards may be offered, depending on country and role.
• Pension or retirement benefits may be offered, depending on country and role.
• 401(k) company match may be offered, depending on country and role.
• Health and wellness programs may be offered, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits may include medical, dental, vision, life, and disability coverage, depending on country and role.
• Paid time off may be offered, depending on country and role.
• Family support benefits may be offered, depending on country and role.

What This Job Offers

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