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 behaviourOrganize and chair the monthly project review meetingOrganize and chair the regular PM forumEnsuring adequate resources for the studies assignedEnsure that the workload of the team(s) or direct reports is adequateDevelopment and performance management of the team(s) or direct reportsEnsure that the everyone in the team or direct reports have development and training plans, according to IDP processContribute to high quality feasibility workContribute to the quality improvement of the study processes and other procedures.Plan and organise coaching of the team members and all direct reportsEnsure that the individual performance planning and review process is completed for all direct reportsPrepare 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 Dev Ops in initiatives/activities as agreed with Dev Ops 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 developmentVery 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
skillsHave the strong communication skills among x-functional stakeholdersProactively 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
