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 aligns with SOPs and ICH/GCP.
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, protocol development, ICH/GCP knowledge, project management, cross-functional team leadership, organizational skills, budget management, vendor management, trial management systems proficiency
Preferred skills
None stated
Technologies
CTMS, TMF, IVRS/IWRS, EDC, Microsoft Project, PowerPoint, Word, Excel
Responsibilities
Lead cross-functional study teams and oversee execution against timelines and budget; provide operational input into protocol development and lead feasibility assessments; oversee site evaluation, selection, and investigator meetings; manage study documentation and systems setup; identify outsourcing needs and manage CRO/vendor contracts; 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 & oversight
