Clinical Study Associate Manager (CSAM)
Regeneron
5 hours ago
On-site
Armonk, NY
Clinical Research and Development
Role: Associate Manager Clinical Study (CSAM)
Responsibilities:
- Support Clinical Study Lead (CSL) by taking responsibility for areas of clinical trial delivery for internally sourced studies and/or studies outsourced to CROs
- Work with internal teams and vendors/CROs across feasibility, planning, initiation, maintenance, and closeout of clinical projects in accordance with GCP, ICH, CFR, and company SOPs
- May lead/oversee planning and management of a clinical study in assigned regions; may contribute to global planning and management
- Contribute to risk assessment and risk mitigation strategies
- Support feasibility assessment to select regions and countries
- Oversee/input to development of study documentation (e.g., CRF, data management plan, monitoring plan, monitoring oversight plan)
- Review site-level informed consents and other patient-facing study start-up materials
- Oversee setup/maintenance of study systems (e.g., CTMS, TMF) and contribute to investigator meeting preparation/execution
- Oversee engagement, contracting, and management of required vendors
- Oversee/input to study drug and clinical supplies forecasting, drug accountability, and drug reconciliation
- Provide regular status reports to stakeholders as requested by CSL
- Contribute to and oversee recruitment/retention strategies; monitor recruitment and retention
- Monitor site activation and monitoring visits
- Support data quality through review of data metrics/listings, protocol deviations, eligibility violations, dosing deviations, and suspected non-compliance; escalate issues to CSL
- Oversee execution of clinical study deliverables against timelines; escalate timeline/budget issues to CSL; support budget management and scope changes
- Contribute to audit/inspection readiness; support inspections and CAPAs
- Manage aspects of study close-out (e.g., database lock; reconciliation of vendor contract; study budget; TMF; study drug accountability)
- May mentor clinical trial management staff
- May be assigned unmasked tasks (e.g., masked/unmasked investigational product support, unmasked TMF setup/management, unmasked data review in EDC, IVRS issue POC, and support oversight of unmasked clinical monitoring)
- Travel to study sites may be required
Qualifications:
- Bachelor’s degree
- 4+ years of relevant clinical trial experience
Benefits (if location-dependent):
- In the U.S., benefits may include health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave)
Application instructions:
- Apply now
Responsibilities:
- Support Clinical Study Lead (CSL) by taking responsibility for areas of clinical trial delivery for internally sourced studies and/or studies outsourced to CROs
- Work with internal teams and vendors/CROs across feasibility, planning, initiation, maintenance, and closeout of clinical projects in accordance with GCP, ICH, CFR, and company SOPs
- May lead/oversee planning and management of a clinical study in assigned regions; may contribute to global planning and management
- Contribute to risk assessment and risk mitigation strategies
- Support feasibility assessment to select regions and countries
- Oversee/input to development of study documentation (e.g., CRF, data management plan, monitoring plan, monitoring oversight plan)
- Review site-level informed consents and other patient-facing study start-up materials
- Oversee setup/maintenance of study systems (e.g., CTMS, TMF) and contribute to investigator meeting preparation/execution
- Oversee engagement, contracting, and management of required vendors
- Oversee/input to study drug and clinical supplies forecasting, drug accountability, and drug reconciliation
- Provide regular status reports to stakeholders as requested by CSL
- Contribute to and oversee recruitment/retention strategies; monitor recruitment and retention
- Monitor site activation and monitoring visits
- Support data quality through review of data metrics/listings, protocol deviations, eligibility violations, dosing deviations, and suspected non-compliance; escalate issues to CSL
- Oversee execution of clinical study deliverables against timelines; escalate timeline/budget issues to CSL; support budget management and scope changes
- Contribute to audit/inspection readiness; support inspections and CAPAs
- Manage aspects of study close-out (e.g., database lock; reconciliation of vendor contract; study budget; TMF; study drug accountability)
- May mentor clinical trial management staff
- May be assigned unmasked tasks (e.g., masked/unmasked investigational product support, unmasked TMF setup/management, unmasked data review in EDC, IVRS issue POC, and support oversight of unmasked clinical monitoring)
- Travel to study sites may be required
Qualifications:
- Bachelor’s degree
- 4+ years of relevant clinical trial experience
Benefits (if location-dependent):
- In the U.S., benefits may include health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave)
Application instructions:
- Apply now