The role requires serving as the SDTL Responsible for planning and leading all components of a clinical study from specifications through closeout to ensure timely, high-quality delivery
Job Summary
The role requires serving as the SDTL Responsible for planning and leading all components of a clinical study from specifications through closeout to ensure timely, high-quality delivery.
Candidates must lead the Local Study Team, ensuring compliance with AstraZeneca procedural documents, ICH-GCP, and local regulations while managing site performance and monitoring activities.
The position involves forecasting study timelines, budgets, and resources, as well as coordinating with investigators and regulatory authorities for successful study execution and data submission.
Matching Summary
The role requires serving as the SDTL Responsible for planning and leading all components of a clinical study from specifications through closeout to ensure timely, high-quality delivery.
Skills & Requirements
Must-have
Lead Local Study Team (LSTL)
5 years R&D Clinical Operations experience
1 year LSTL role experience
ICH-GCP and local regulatory compliance
Study timeline and budget management
Investigator site selection and recruitment strategy
Nice-to-have
Mentoring and staff competency development
Experience with IMPACT and ACCORD systems
Strong stakeholder communication skills
Knowledge of clinical trial submission processes
Key Requirements
University degree in biological science or healthcare
Minimum 5 years in R&D Clinical Operations
At least 1 year working as LSTL
Excellent spoken and written English proficiency
Work Rights
Must have right to work in the country/ies where the role is advertised