Clinical Study Associate Manager
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 by taking responsibility for areas of clinical trial delivery, across both internally sourced studies and studies outsourced to CROs, while collaborating with internal study-team members and external vendors. The position 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. It oversees or contributes to study documentation, systems, vendors, clinical supplies, recruitment and retention, data quality, timelines, budgets, audit and inspection readiness, and study close-out activities. The role may mentor clinical trial management staff and may be assigned unmasked study tasks. The position is primarily on-site with hybrid flexibility and is based in Armonk, New York; Warren, New Jersey; or Cambridge, Massachusetts. Travel may be required up to 25%.
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 ability to deliver specific study activities.
- Technical proficiency with trial management systems and Microsoft applications, including Project, PowerPoint, Word, Excel, 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
- Lead or oversee planning and management of a clinical study in assigned regions in alignment with global study plans, and contribute to global study planning and management as applicable.
- Contribute to risk assessment, identify risk mitigation strategies, and support feasibility assessment to select relevant 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 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 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 the development and oversee implementation of recruitment and retention strategies; 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 and escalate timeline or budget issues to the Clinical Study Lead.
- 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.
- Mentor clinical trial management staff as applicable and perform 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
