Clinical Study Associate Manager (CSAM)

Job description

The Associate Manager Clinical Study (CSAM) role supports the Clinical Study Lead (CSL) by taking responsibility for areas of clinical trial delivery. This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs) and the balance of direct execution versus oversight of CROs deliverables will vary accordingly. The Assoc Mgr Clinical Study works 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. A typical day in this role looks like: 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 limi...