Temporary - Clinical Study Associate Manager

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

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