[Alexion] Country Study Manager
Core
Country Study Manager responsible for overseeing the end-to-end operational delivery of clinical trials within a specific country, ensuring quality, timeliness, and recruitment targets.
Role type
Senior Clinical Operations Manager (Country Study)
Builds
Clinical trials for pharmaceutical products
Domain
Life Sciences / Clinical Research / Pharma
Deliverable
client delivery
Required skills
Clinical trial process oversight, site feasibility, regulatory documentation review, contract negotiation, recruitment strategy, CRA oversight, inspection readiness, risk management, training coordination
Preferred skills
Management experience, change management, matrix organization navigation, RBQM principles
Technologies
CTMS, eTMF, MS Office Suite
Responsibilities
Oversee site identification, feasibility, startup, recruitment, and closeout; Negotiate site contracts and budgets; Manage local regulatory submissions and documentation; Lead recruitment discussions and develop enrollment plans; Coordinate CRA training and oversight; Ensure inspection readiness; Drive quality efforts and risk management; Train and advise investigators on GCP and RBQM.
Seniority
Senior, hands-on IC with management responsibilities
