Clinical Study Associate Manager

Regeneron Pharmaceuticals • Warren, MI

1d

About The Position

Regeneron is seeking a Clinical Study Associate Manager to support the Clinical Study Lead in delivering clinical trials. The role covers assigned areas of trial delivery for both internally sourced studies and studies outsourced to CROs, working with internal study teams and external vendors. The position is based in Armonk, NY; Warren, NJ; or Cambridge, MA, and may require up to 25% travel.

The Associate Manager may lead or oversee planning and management of a clinical study in assigned regions, contribute to global study planning, and oversee study activities from start-up through close-out. Responsibilities include supporting study documentation and systems, vendor and clinical supply management, recruitment and data quality, budget and timeline oversight, and audit and inspection readiness. The role may include mentoring clinical trial management staff and performing assigned unmasked study tasks.

Regeneron describes a competitive total rewards package that may vary by country and role. For the United States, it may include annual bonuses or other incentives, equity awards, retirement benefits including a 401(k) company match, health and wellness programs, fitness centers, insurance benefits, paid time off, and family support benefits.

Requirements

• Bachelor's degree and 4 or more years of relevant industry experience.
• A 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 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 and 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 assessments, identify risk mitigation strategies, and support feasibility assessments for selecting 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 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 clinical 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 budgets, the TMF, and study drug accountability.
• May mentor clinical trial management staff and may perform 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, including a 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.
• 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