Clinical Study Manager, Trials Delivery and Partnerships

Regeneron Pharmaceuticals; New Jersey; On-site; USD 112,000 - 183,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Clinical Study Associate Manager to support clinical trial delivery and collaborate with internal teams and CROs to advance studies. You will contribute to study planning, risk mitigation, and documentation while ensuring quality and timelines.

The role covers managing study systems (CTMS/TMF), vendor relationships, recruitment strategies, data quality, and budget awareness. Travel requirements and on-site collaboration may apply.

Qualifications

• Bachelor's Degree and 4+ years of relevant industry experience.
• A data driven approach to executing and problem solving, and attention to details for the ability to deliver on specific study activities.
• Technical proficiency in trial management systems and MS applications including Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF.
• Budget awareness with the ability to participate in various aspects of budget management.
• Familiarity with medical terms, and vendor management experience.
• Experience in clinical trial operations including experience developing key study documents.
• Knowledge of ICH/GCP and regulatory guidelines/directives.

Responsibilities

• May lead/oversee the planning and management of a clinical study in assigned region(s).
• Contributes to risk assessment and mitigation strategies and supports feasibility assessment for region/country selection.
• Oversees development and review of study documentation (CRF, data management plan, monitoring plan).
• Oversees setup and maintenance of study systems including CTMS and TMF.
• Manages engagement with vendors and forecasting of study drug and clinical supplies.
• Provides status reports and supports recruitment/retention strategies.
• Monitors recruitment, site activation progress, and monitoring visits.
• Supports data quality reviews and escalation of data issues.
• Oversees deliverables against timelines and budget; supports inspections and CAPAs.
• Manages study close-out activities including database lock and TMF reconciliation; may mentor staff.

Skills

Data driven approach

Detail oriented

Budget awareness

Vendor management

Clinical trial operations

ICH/GCP knowledge

Education

Bachelor's Degree

Tools

EDC

TMF

CTMS

IVRS/IWRS

MS Office

Job description

Regeneron Pharmaceuticals is seeking a Clinical Study Associate Manager to support clinical trial delivery and collaborate with internal teams and CROs to advance studies. You will contribute to study planning, risk mitigation, and documentation while ensuring quality and timelines.

The role covers managing study systems (CTMS/TMF), vendor relationships, recruitment strategies, data quality, and budget awareness. Travel requirements and on-site collaboration may apply.