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The Clinical Study Associate Manager (CSAM) role supports the Clinical Study Lead by taking responsibility for areas of clinical trial delivery. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct execution versus oversight of CROs deliverables will vary accordingly. You will work with the study team internally and externally with vendors such as CROs in feasibility, planning, initiation, maintenance and closeout of clinical projects according to GCP, ICH, CFR and Regeneron Standard Operating Procedures (SOPs). Travel to study sites may be required to assist with monitoring clinical studies.
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Join a Legacy of Innovation 110 Years and Counting!
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The Manager Statistical Programmer will lead and support all programming activities per the project strategies within therapeutic area(s). The incumbent will work with management and study team, plan and manage the implementation and execution of programming project standard to support from the single study through to regulatory approval, product launch, data monitoring boards, regulatory safety reports, and other requests.