Clinical Study Associate Manager (CSAM)
Regeneron
5 hours ago
On-site
Armonk, NY
Clinical Research and Development
Responsibilities:
- Support the Clinical Study Lead (CSL) by taking responsibility for areas of clinical trial delivery across feasibility, planning, initiation, maintenance, and closeout (including internally sourced and CRO-oversight studies).
- Lead/oversee planning and management of a clinical study in assigned region(s) aligned with global study plans; contribute to global study planning.
- Contribute to risk assessment and identify risk mitigation strategies.
- Support feasibility assessment to select relevant regions and countries.
- Oversee and provide input to study-specific documentation (e.g., CRF, data management plan, monitoring plan, monitoring oversight plan).
- Review site-level informed consents and other patient-facing start-up materials.
- Oversee setup and 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 stakeholder status reports as requested.
- Develop and oversee recruitment and retention strategies; monitor recruitment/retention.
- Monitor progress for site activation and monitoring visits.
- Support data quality (data metrics/listings, protocol deviations, eligibility violations, dosing deviations, suspected non-compliance); escalate issues to the CSL.
- Oversee execution of clinical study deliverables against planned timelines; escalate timeline/budget issues.
- Support accurate budget management and scope changes.
- Contribute to clinical project audit/inspection readiness; support inspections and contribute to CAPAs.
- Manage aspects of study close-out (database lock; reconcile vendor contract; study budget; TMF; study drug accountability).
- May mentor clinical trial management staff.
- May be assigned unmasked tasks (e.g., unmasked TMF management, review of unmasked EDC data, IVRS issue point of contact, support oversight of unmasked monitoring).
Qualifications/Requirements:
- Bachelor’s degree.
- 4+ years of relevant clinical trial experience.
Skills/Experience/Knowledge:
- Clinical trial delivery across the study lifecycle and collaboration with internal teams and external vendors/CROs.
- Knowledge and execution aligned with GCP, ICH, CFR, and applicable SOPs.
Benefits (if explicitly stated):
- Salary range (annually): $109,900.00 - $179,300.00.
Application instructions:
- Apply now to take your first step toward living the Regeneron Way.
- Support the Clinical Study Lead (CSL) by taking responsibility for areas of clinical trial delivery across feasibility, planning, initiation, maintenance, and closeout (including internally sourced and CRO-oversight studies).
- Lead/oversee planning and management of a clinical study in assigned region(s) aligned with global study plans; contribute to global study planning.
- Contribute to risk assessment and identify risk mitigation strategies.
- Support feasibility assessment to select relevant regions and countries.
- Oversee and provide input to study-specific documentation (e.g., CRF, data management plan, monitoring plan, monitoring oversight plan).
- Review site-level informed consents and other patient-facing start-up materials.
- Oversee setup and 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 stakeholder status reports as requested.
- Develop and oversee recruitment and retention strategies; monitor recruitment/retention.
- Monitor progress for site activation and monitoring visits.
- Support data quality (data metrics/listings, protocol deviations, eligibility violations, dosing deviations, suspected non-compliance); escalate issues to the CSL.
- Oversee execution of clinical study deliverables against planned timelines; escalate timeline/budget issues.
- Support accurate budget management and scope changes.
- Contribute to clinical project audit/inspection readiness; support inspections and contribute to CAPAs.
- Manage aspects of study close-out (database lock; reconcile vendor contract; study budget; TMF; study drug accountability).
- May mentor clinical trial management staff.
- May be assigned unmasked tasks (e.g., unmasked TMF management, review of unmasked EDC data, IVRS issue point of contact, support oversight of unmasked monitoring).
Qualifications/Requirements:
- Bachelor’s degree.
- 4+ years of relevant clinical trial experience.
Skills/Experience/Knowledge:
- Clinical trial delivery across the study lifecycle and collaboration with internal teams and external vendors/CROs.
- Knowledge and execution aligned with GCP, ICH, CFR, and applicable SOPs.
Benefits (if explicitly stated):
- Salary range (annually): $109,900.00 - $179,300.00.
Application instructions:
- Apply now to take your first step toward living the Regeneron Way.