Clinical Study Associate Manager
Core
Lead and oversee the planning and management of clinical studies, ensuring delivery against timelines and budgets while managing vendor engagement and data quality.
Role type
Senior Clinical Study Associate Manager
Builds
Clinical trial operations and study deliverables
Domain
Biopharmaceuticals / Clinical Research
Required skills
Clinical trial operations, Vendor management, Study documentation development, Risk assessment, Budget management, Data quality monitoring, Regulatory guidelines knowledge (ICH/GCP), Trial management systems proficiency
Preferred skills
Mentorship of clinical trial staff, Global study planning, Site activation and monitoring oversight
Technologies
CTMS, TMF, IVRS/IWRS, EDC, MS Project, MS Excel, MS PowerPoint, MS Word
Responsibilities
Lead planning and management of clinical studies in assigned regions; Oversee vendor engagement, contracting, and management; Monitor recruitment, retention, and site activation progress; Support data quality reviews and escalate issues; Manage study close-out activities including database lock and budget reconciliation; Contribute to audit and inspection readiness.
Seniority
Senior, hands-on IC