Clinical Study Manager: Trials Delivery & Vendor Oversight

Regeneron Pharmaceuticals, Inc.; Armonk (NY); Hybrid; USD 110,000 - 179,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Associate Manager to join our Clinical Trial management team in an on-site role with hybrid flexibility.

You will support the Clinical Study Lead by managing trial delivery for both internal and CRO-sourced studies, coordinating with vendors, and ensuring timelines and budgets are met. The role involves overseeing study documentation, CTMS/TMF setup, recruitment strategies, data quality reviews, and collaboration with global study

Qualifications

• Bachelor's Degree and 4+ years of relevant industry experience.
• 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 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

Data-driven

Attention to detail

Trial management systems

MS Office

IVRS/IWRS

EDC

TMF

Budgeting

Vendor management

ICH/GCP

Education

Bachelor's degree

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Associate Manager to join our Clinical Trial management team in an on-site role with hybrid flexibility.

You will support the Clinical Study Lead by managing trial delivery for both internal and CRO-sourced studies, coordinating with vendors, and ensuring timelines and budgets are met. The role involves overseeing study documentation, CTMS/TMF setup, recruitment strategies, data quality reviews, and collaboration with global study