Manager, Clinical Study Lead
Core
Accountable for the global execution of assigned smaller or less complex clinical trials from study design through close out, ensuring conduct per ICH/GCP and Regeneron SOPs.
Role type
Manager, Clinical Study Lead
Builds
Clinical trials (internally sourced and outsourced to CROs)
Domain
Biopharmaceuticals / Clinical Operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global clinical trial operations, ICH/GCP regulatory knowledge, budget management, vendor/CRO management, trial management systems (CTMS, TMF, EDC, IVRS/IWRS), project management, cross-functional team leadership, site evaluation and selection, patient recruitment strategies, study close-out management, staff supervision and mentoring
Preferred skills
Process improvement initiatives, innovative global approaches to study execution
Technologies
CTMS, TMF, EDC, IVRS, IWRS, Microsoft Project, PowerPoint, Word, Excel
Responsibilities
Lead cross-functional study teams and serve as primary point of contact for leadership; oversee execution against timelines, deliverables, and budget; provide operational input into protocol development and feasibility assessments; oversee site evaluation, selection, and investigator meetings; manage study documentation and systems setup; identify outsourcing needs and manage vendor contracting; manage baseline budgets and scope changes; lead risk assessment, site monitoring, and patient recruitment strategies; manage study close-out activities; supervise Clinical Study Management staff and drive process improvements
Seniority
Manager, direct leadership of staff
