[Alexion] Clinical Research Associate (Fixed Term)
Core
Monitoring clinical studies at assigned sites to ensure delivery, compliance, and data quality for Alexion's therapeutic areas.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trials for rare medical conditions
Domain
Biopharmaceuticals / Clinical Research
Required skills
Clinical monitoring, site selection and initiation, data review, recruitment management, regulatory document handling, audit preparation, ICH-GCP compliance, risk-based quality management
Preferred skills
Experience in all study phases, rare medical conditions, matrix reporting structure adaptability, process improvement, stakeholder communication
Technologies
CTMS, eTMF, electronic messaging systems
Responsibilities
Perform identification, selection, initiation, monitoring, site data review, and closeout activities; Drive site performance and resolve study-related issues; Train and advise investigators on study matters; Develop recruitment plans and manage enrollment; Ensure monitoring KPIs are met; Prepare monitoring visit reports; Collect and upload essential documents to eTMF; Support study start-up and regulatory maintenance; Collaborate with Medical Affairs and other stakeholders; Prepare for audits and regulatory inspections.
Seniority
Mid-level, hands-on IC