Clinical Study Associate Manager
Core
Manage clinical trial delivery for internally sourced and outsourced studies, ensuring adherence to global plans and timelines.
Role type
Senior Clinical Study Associate Manager
Builds
Clinical trial operations and deliverables for life-changing medicines
Domain
Biopharmaceuticals / Clinical Research
Deliverable
client delivery
Required skills
Clinical trial operations, vendor management, study documentation development, risk assessment, budget management, data quality monitoring, regulatory compliance (ICH/GCP), site activation and monitoring oversight
Preferred skills
Experience with CROs, mentorship of trial management staff
Technologies
CTMS, TMF, IVRS/IWRS, EDC, MS Project, PowerPoint, Word, Excel
Responsibilities
Lead planning and management of clinical studies in assigned regions; oversee vendor engagement, contracting, and drug accountability; monitor recruitment, retention, and site activation progress; support data quality reviews and protocol deviation analysis; manage study close-out activities including database lock and TMF reconciliation; contribute to audit and inspection readiness.
Seniority
Senior, hands-on IC with mentorship responsibilities
