Study Start Up Manager
Core
Lead country-level clinical study start-up activities to accelerate site activations, manage regulatory/ethics submissions, and ensure compliance with ICH-GCP and local regulations.
Role type
Senior Clinical Study Start-Up Lead
Builds
Clinical trial start-up infrastructure and site readiness for AstraZeneca medicines
Domain
Life Sciences / Clinical Operations
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study start-up leadership, Regulatory documentation management, Authority and ethics submissions, Feasibility and planning, Cross-functional collaboration, Systems and data integrity, eTMF quality management, Risk and performance management, Veeva Vault, Informed consent review, Language negotiation, Clinical trial process knowledge (Phases II–IV), ICH GCP, Project management, Vendor management
Preferred skills
Multi-center/multi-country start-up leadership, Direct interaction with ethics committees/health authorities, eClinical ecosystem familiarity, Playbook/KPI design, Additional languages
Technologies
Veeva Vault, CTMS, eTMF
Responsibilities
Own all start-up activities at the country level ensuring compliance; Serve as main point of contact for sites leading informed consent reviews and language negotiations; Prepare and manage site and country regulatory documentation; Lead submissions to Regulatory Authorities and IEC/IRB; Contribute to clinical and operational feasibility assessments; Partner with CRAs and Local Study Team to achieve milestones; Update CTMS with accurate site data; Ensure eTMF document collection and QC; Proactively manage outstanding actions and report on milestones/risks.
Seniority
Senior, hands-on IC