AstraZeneca
Pharmaceutical
LocalStudyAssociateDirector
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“Local Study Associate Director at AstraZeneca. Skills: Clinical Study Management, ICH-GCP, Country regulations, Team leadership. Lead delivery of country-level study commitments. Guide Local Study Teams”
What You'll Achieve.
Meet agreed timelines; Meet budgets; Meet quality standards; Deliver high-quality data; Achieve optimal performance; Ensure compliance; Assess suitability; Assess quality risk; Support delivery of submissions; Maintain current study budgets; Ensure effective set-up; Ensure ongoing management; Drive quality; Drive consistency; Drive development; Facilitate rapid resolution; Enable transparent communication; Enable issue resolution; Enable aligned decision-making; Support smooth study execution; Support enrolment targets; Ensure timely risk identification; Ensure timely risk mitigation; Support study delivery; Support scientific quality; Ensure quality delivery; Ensure adherence to procedures; Maintain eTMF inspection-ready; Ensure documentation is complete; Ensure documentation is accurate; Ensure documentation is current; Plan and lead audit activities; Plan and lead inspection activities; Inform local strategy; Support optimal study delivery; Support scientific quality
Industry & Context.
Problem Solving; Issue Management; Risk identification; Risk mitigation; Troubleshooting
Ability to travel nationally, Ability to travel internationally, Valid driving license
What They're Looking For.
Must Have
Bachelor's degree in related discipline, 5+ years pharmaceutical industry experience, Knowledge of drug development process, Knowledge of GxP processes, Knowledge of ICH-GCP, Knowledge of relevant country regulations, Medical knowledge, Ability to learn AZ Therapeutic Areas, Clinical Study Management experience, Project management experience, Monitoring experience, Study drug handling experience, Data management experience, Fluency in written business-level English, Fluency in spoken business-level English, Ability to travel nationally, Ability to travel internationally, Valid driving license
Nice to Have
Bachelor's degree in life sciences, Previous experience in Clinical Operations, Previous experience as CRA, Previous experience as SrCRA, Previous experience in Medical Affairs-led studies, Previous experience in Academic-led studies
What You'll Do.
Lead delivery of country-level study commitments
Guide Local Study Teams
Meet agreed timelines
Meet quality standards
Ensure studies are designed in compliance
Ensure studies are set up in compliance
Ensure studies are conducted in compliance
Ensure studies are closed in compliance
Ensure compliance with AstraZeneca Procedural Documents
Ensure compliance with ICH-GCP
Ensure compliance with local regulations
Oversee feasibility assessments
Oversee site selection
Coordinate site selection process
Identify potential sites
Identify potential investigators
Conduct initial site quality risk assessments
Conduct Site Qualification Visits
Ensure timely submission to Ethics Committees
Ensure timely submission to IRBs
Support delivery of submissions to Regulatory Authorities
Prepare country-level financial agreements
Maintain current study budgets
Ensure effective study set-up
Ensure ongoing study management
Oversee monitoring activities
Manage monitoring activities
Coordinate monitoring activities
Review monitoring visit reports
Provide guidance to monitors
Conduct co-monitoring visits
Conduct accompanied site visits
Conduct training visits
Identify risks proactively
Facilitate rapid resolution of issues
Escalate issues when necessary
Organize Local Study Team meetings
Lead Local Study Team meetings
Enable transparent communication
Enable issue resolution
Enable aligned decision-making
Build working relationships with Local Study Team members
Build working relationships with site staff
Build working relationships with global stakeholders
Report study progress
Report mitigation plans
Contribute to patient recruitment strategies
Maintain regular contact with investigators
Support enrolment targets
Develop country risk management plan
Maintain country risk management plan
Review country risk management plan
Ensure timely risk identification
Ensure timely risk mitigation
Coordinate with National Coordinating Investigator
Coordinate with National Lead Investigator
Plan National Investigator Meetings
Lead National Investigator Meetings
Support forecasting for study timelines
Support forecasting for resource needs
Support forecasting for recruitment
Support forecasting for budgeting
Support forecasting for materials
Support forecasting for investigational product supply
Ensure set-up of business-critical systems
Ensure updating of business-critical systems
Ensure access to business-critical systems
Ensure accuracy of study payments
Ensure compliance of study payments
Participate in training of new Local Study Team
Participate in coaching of new Local Study Team
Plan audit activities
Lead audit activities
Plan regulatory inspection activities
Lead regulatory inspection activities
Contribute insights to process development
Contribute insights to continuous improvement initiatives
Keep line managers informed about study status
Keep line managers informed about milestones
Keep line managers informed about key issues
Keep line managers informed about team performance
Ensure full compliance with local policies
Ensure full compliance with codes of ethics
Ensure full compliance with business practices
Provide feedback on research trends
Provide feedback on competing studies
Provide feedback on site insights
Provide feedback on investigator insights
Collaborate with local Medical Affairs team
Support optimal study delivery
Support scientific quality
Support SMM initiatives
How You'll Work.
Team & Collaboration
Local Study Teams; Global Study Teams; Local leadership; Site staff; Global stakeholders; National Coordinating Investigator; National Lead Investigator; Medical Affairs team; Quality Assurance teams
Communication Scope
Written business-level English; Spoken business-level English; Impactful Site conversations
Process & Methodology
Project management, Clinical Study Management
Full Job Description
**Local Study Associate Director** **Introduction to role** The Local Study Associate Director leads the delivery of country-level clinical study commitments, guiding Local Study Teams to meet agreed timelines, budgets and quality standards. This role works in close alignment with Global Study Teams and local leadership to ensure that studies are designed, set up, conducted, and closed in full compliance with AstraZeneca Procedural Documents, ICH-GCP and local regulations. From feasibility and site selection through monitoring and inspection readiness, the Local Study Associate Director plays a central role in turning innovative oncology science into robust clinical evidence that can change patient outcomes. Ready to shape how complex oncology trials are delivered in practice? **Accountabilities** * Hold overall accountability for meeting country-level study commitments, ensuring timely delivery of high-quality data. * Lead Local Study Teams for assigned studies, including CRAs, CSAs and other contributors, promoting collaboration, clarity of roles and strong performance. * Drive optimal performance and compliance of Local Study Teams with AstraZeneca Procedural Documents, ICH-GCP requirements and local regulations. * Oversee high-quality clinical and operational feasibility assessments for potential studies, providing robust input into study selection and design. * Coordinate and manage the site selection process, including identification of potential sites and investigators, initial site quality risk assessments and, where needed, Site Qualification Visits to assess suitability and quality risk. * Ensure timely submission of applications and documentation to Ethics Committees/IRBs and, in partnership with Regulatory Affairs, support delivery of submissions to Regulatory Authorities in line with local requirements. * Prepare accurate country-level financial agreements and maintain current study budgets within the clinical financial system, working closely with Dire
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