Local Study Associate Director
AstraZeneca
full-time
Posted on:
Location Type: Office
Location: Wilmington • United States
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Job Level
Tech Stack
About the role
- Lead Local Study Teams to ensure successful delivery of country-level study commitments
- Manage clinical studies with precision, adhering to AstraZeneca's procedural documents, international guidelines, and local regulations
- Coordinate and oversee the site selection process, identifying potential sites and investigators
- Ensure timely submission of required applications and documentation to Ethics Committees/IRBs
- Prepare accurate country-level financial agreements and maintain up-to-date study budgets
- Conduct required co-monitoring visits, accompanied site visits, and training visits with study CRAs
Requirements
- Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification
- 0+ years experience in the pharmaceutical industry, preferably in Clinical Operations (CRA, SrCRA) or other related fields
- Relevant knowledge and ability to fulfil key responsibilities, including but not limited to: Drug development process and related GxP processes, International guidelines ICH-GCP, relevant country regulations, medical knowledge and ability to learn relevant AZ Therapeutic Areas, Clinical Study Management including project management, monitoring, study drug handling and data management.
Benefits
- Health insurance
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical study managementproject managementdata managementstudy drug handlingGxP processesICH-GCPfinancial agreementsbudget managementsite selectionmonitoring
Soft Skills
leadershipcommunicationorganizational skillsteam coordinationattention to detailproblem-solvingtraininginterpersonal skillstime managementadaptability