Temporary - Clinical Study Associate Manager

Regeneron; New Jersey; On-site; USD 90,000 - 130,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Temporary Clinical Study Associate Manager to support the Clinical Trial management team. You will assist the Study Lead in delivering studies and coordinating with CROs.

Responsibilities include planning, risk mitigation, study documentation, CTMS/TMF setup and maintenance, and budget oversight.

You will work with vendors, monitor site activity, ensure data quality, and contribute to inspections readiness and study close-out.

Qualifications

• Bachelor's degree required with 4+ years in clinical trial operations or equivalent.

Responsibilities

• Lead or oversee planning and management of clinical studies in assigned regions.
• Contribute to risk assessment and mitigation planning.
• Oversee study documentation development and site start-up materials.
• Maintain CTMS and TMF systems; support investigator meeting activities.
• Engage, contract, and manage vendors for the study.
• Monitor recruitment, data quality, and site activity.
• Support budget management and scope changes.
• Assist in audits, inspections, and CAPAs as needed.
• Oversee study close-out activities including database lock and drug accountability.

Skills

Data-driven approach

Trial management systems

MS Office (Project, PowerPoint, Word,‑

Budget management

Vendor management

ICH/GCP knowledge

Education

Bachelor's Degree

Tools

IVRS/IWRS

EDC

TMF

Job description

Temporary - Clinical Study Associate Manager - R50603

Location

Armonk, NY, Warren, NJ

Position Description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Clinical Study Associate Manager to join our Clinical Trial management team. In this role, you will support the Clinical Study Lead by taking responsibility for areas of clinical trial delivery, applying to both internally sourced studies and studies out-sourced to CROs, while collaborating with the study team internally and externally with vendors such as CROs.

Roles Responsibilities

• May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignment with global study plans, and may contribute to global planning and management of the study
• Contributes to risk assessment and helps identify risk mitigation strategies, and supports feasibility assessment to select relevant regions and countries
• Oversees and provides input to the development of study specific documentation (e.g., CRF, data management plan, monitoring plan, monitoring oversight plan) and reviews site level informed consents and other patient-facing study start-up materials
• Oversees setting up and maintenance of study systems including CTMS and TMF, and contributes to investigator meeting preparation and execution
• Oversees engagement, contracting and management of required vendors for the study, and oversees and provides input to study drug and clinical supplies' forecasting, drug accountability and drug reconciliation
• Provides regular status reports to collaborators as requested by the Clinical Study Lead, and contributes to development of and oversees implementation of recruitment and retention strategies
• Monitors recruitment and retention, and monitors progress for site activation and monitoring visits
• Supports data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites, and escalates data flow and data quality issues to Clinical Study Lead
• Oversees the execution of the specific clinical study deliverables against planned timelines, escalates issues related to timelines or budget to Clinical Study Lead, and supports accurate budget management and scope changes
• Contributes to clinical project audit and inspection readiness throughout the study lifecycle, and supports internal and external inspection activities and contributes to CAPAs as required
• Manages aspects of study close-out activities including database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability, may mentor clinical trial management staff, and may be assigned unmasked tasks for studies (e.g., unmasked TMF management, unmasked data review, IVRS point of contact)

Skills

• 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

Education

• Bachelor's Degree