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Regeneron · 23 hours ago

Clinical Study Associate Manager (CSAM)

Warren, NJ

Full-time

Onsite

Mid Level

$110K/yr - $179K/yr

4+ years exp

Regeneron is a biopharmaceutical company that focuses on developing medicines for serious diseases. The Associate Manager Clinical Study (CSAM) role supports the Clinical Study Lead by managing clinical trial delivery, overseeing vendor engagement, and ensuring compliance with regulatory standards throughout the study lifecycle.

BiopharmaBiotechnologyPharmaceutical

Comp. & Benefits

Responsibilities

May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignment with the global study plans and may contribute to global planning and management of the study

Contributes to risk assessment and helps identify risk mitigation strategies

Supports feasibility assessment to select relevant regions and countries

Oversees and provides input to the development of study specific documentation including but not limited to: case report form (CRF), data management plan, monitoring plan, monitoring oversight plan, etc

Reviews site level informed consents and other patient-facing study start-up materials

Oversees setting up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS) and Trial Master File (TMF) Contributes to investigator meeting preparation and execution

Oversees engagement, contracting and management of required vendors for the study

Oversees and provides input to study drug and clinical supplies forecasting, drug accountability and drug reconciliation

Provides regular status reports to stakeholders as requested by the Clinical Study Lead

Contributes to development of and oversees implementation of recruitment and retention strategies

Monitors recruitment and retention

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

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

Supports accurate budget management and scope changes

Contributes to clinical project audit and inspection readiness throughout the study lifecycle

Supports internal and external inspection activities and contributes to CAPAs as required

Manages aspects of study close-out activities including but not limited to database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability

May be responsible for mentoring clinical trial management staff

May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring

Qualification

Clinical trial managementGCPICHCFRClinical Trial Management System (CTMS)Trial Master File (TMF)Risk assessmentData quality managementBudget managementMentoringCommunicationTeam collaboration