AstraZeneca

Senior Manager, Country Study Management – Cell Therapy

AstraZeneca

full-time

Posted on:

Location Type: Office

Location: Beijing • China

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • 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.
  • This role represents country study management function, working with the Director of Country Study Management to develop the capability of the whole local study manager team.
  • Ensure that the workload of the team(s) or direct reports is adequate.
  • 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 and the quality improvement of the study processes and other procedures.
  • Plan and organize coaching of the team members and all direct reports.
  • Prepare salary and bonus proposals of all team members or direct reports based on their performance in close collaboration with responsible country study management Director and HR partner.

Requirements

  • 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.
  • 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 CRO management experience and skills.
  • Have strong communication skills among x-functional stakeholders.
  • Proactively engage KOLs in the targeted TAs to secure investigator relationship with a systematic mechanism.
Benefits
  • AstraZeneca embraces diversity and equality of opportunity.
  • We are committed to building an inclusive and diverse team representing all backgrounds.
  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Clinical OperationsClinical Study ProcessMonitoring ProcessStudy Drug Handling ProcessData Management ProcessDrug Development ProcessAZ Procedural DocumentsICH/GCP guidelinesCRO management
Soft Skills
team buildingorganizational developmentcommunication skillscoachingadaptabilityquality improvementperformance managementstakeholder engagement