AstraZeneca

Associate Director, Country Study Management is accountable for delivering the committed part of all clinical interventional studies under their supervision according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations. This role represents country study management function, work with the Director of Coutnry Study Management to develop the capability of whole local study manager team.

As assigned, this role is accountable that study sites are identified, site qualifications performed, set up (as appropriate), initiated, monitored, closed and documentation archived.

Typical Accountabilities

• Leadership of group work and building the team spirit, including developing team style and behaviour
• Organize and chair the monthly project review meeting
• Organize and chair the regular PM forum
• Ensuring adequate resources for the studies assigned
• Ensure that the workload of the team(s) or direct reports is adequate
• Development and performance management of the team(s) or direct reports
• Ensure that the everyone in the team or direct reports have development and training plans, according to IDP process
• Contribute to high quality feasibility work
• Contribute to the quality improvement of the study processes and other procedures.
• Plan and organise coaching of the team members and all direct reports
• Ensure that the individual performance planning and review process is completed for all direct reports
• Prepare salary and bonus proposals of all team members or direct reports based on their performance in close collaboration with responsbible country study management Director and HR partner.
• Ensure all systems are continuously updated.
• Support Local Study Leader(LSL)/teams in forecasting study timelines, resources, recruitment, study materials and drugs.
• Provide direction to LSL/teams on major study commitments including resolving any key issues identified.
• Perform necessary accompanied site visits for direct reports, supporting ongoing coaching and development.
• Support DevOps in initiatives/activities as agreed with DevOps leaders.

Education, Qualifications, Skills and Experience:

• University degree in biological science or
• healthcare-related field, or equivalent.
• Minimum 6 years(F1)/8 years(F2) experience in
• Clinical Operations (CRA / Sr. CRA / CSM) or other
• related fields.
• Proven team building and people/organizational
• development skills.
• Excellent knowledge of spoken and written English.
• Good ability to learn and to adapt to work with IT
• systems.
• Provide direct support and supervision of Clinical
• Local study managers to execute clinical project,
• including staff selection, project assignment, overall
• training, and completion of goals, development
• plans, performance reviews and talent development
• Very good knowledge of the Clinical Study Process, AZ Procedural Documents and international ICH/GCP guidelines.
• Excellent knowledge of the Monitoring Process.
• Good understanding of the Study Drug Handling Process and the Data Management Process.
• Good knowledge of relevant local regulations.
• Good medical knowledge in relevant AZ Therapeutic Areas.
• Good knowledge of the Drug Development Process.
• Ability to deliver quality according to the requested
• standards.
• Ability to look for and champion more efficient and
• effective methods/processes of delivering quality
• clinical trials with reduced budget and in less time.
• Have rich of CRO management experience and
• skills
• Have the strong communication skills among x-functional stakeholders
• Proactively engagement KOLs in the targeted TAs
• to secure investigator relationship with a systematic
• mechanism.

Date Posted

12-6月-2025

Closing Date

30-10月-2025

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.