BPM Evidence Associate (fixed term/secondment)
Core
Coordinate and support the operational delivery of global strategic studies, including company-sponsored research, externally sponsored research, and early access programs, to generate evidence for AstraZeneca therapies.
Role type
Senior operational project coordinator (clinical research)
Builds
Evidence packages for regulatory submissions and market access
Domain
Biopharmaceuticals / Clinical Research Operations
Required skills
Study lifecycle management, CRO/ESP coordination, eTMF management, financial tracking, regulatory compliance, risk mitigation, stakeholder communication
Preferred skills
Experience with Veeva systems, knowledge of GCP and ICH guidelines, project management certification
Technologies
Veeva Clinical Vault, Veeva Quality Vault, SharePoint, TRIALSCOPE DISCLOSE, ACCORD, COUPA, OPAL
Responsibilities
Coordinate administrative tasks for study start-up, execution, and close-out; manage eTMF setup and archiving; oversee CRO/ESP collaboration and financial aspects; ensure compliance with SOPs and regulations; lead governing body meetings; track project KPIs for time, cost, and quality.
Seniority
Mid-Senior, hands-on IC
