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Seoul, Seoul, Korea, Republic Of
Job reference: R-040402
Posted date: Dec. 06, 2018


To be responsible for co-ordinating the implementation of global and local Clinical Development processes, Clinical Procedural Documents, Quality & Compliance Manual documents.

To ensure that local Procedural Documents are compliant with global AZ Procedural Documents, applicable international guidelines such as ICH/GCP as well as relevant local regulations.

To provide advice and training on Clinical Development processes, Clinical Procedural Documents, applicable Quality & Compliance Manual documents, international Good Clinical Practice standards and local regulations to all relevant MC-CRR employees and external collaborators.

To plan Quality Control activities and to perform them in collaboration with line managers.

Principal accountabilities include:

  • Co-ordinate the implementation of Global and Local Clinical Development procedures
  • Make all Procedural Documents (e.g. AZeD) available to the local organisation.
  • Co-ordinate the development, publication, implementation, maintenance and archiving of Local Procedural Documents, ensuring that they comply with global Clinical Procedural Documents, applicable Quality & Compliance manual documents, international guidelines such as ICH/GCP and local regulations.
  • Co-ordinate training on all the above to relevant MC-CRR staff, according to plans from Clinical Learning & Development group in consultation with relevant line managers.
  • Ensure the training records for all relevant staff are maintained.
  • Responsible for local adaptation of Global training material as well as coordinating the creation of training material for local Procedural Documents including archiving of local materials.
  • Provide advice to Local Study Delivery Teams and other MC-CRR personnel on Clinical Development processes, Procedural Documents, applicable Quality & Compliance manual documents, international guidelines such as ICH/GCP and local regulations.
  • Provide training to Investigational Site staff on GCP, ICH and local regulations, when required by the Local Study Delivery Team.
  • Lead the Local Site Compliance Team or equivalent.
  • Support local management in the planning and conduct of quality control activities.
  • Provide advice to Local Study Delivery Teams in the planning of quality control of Clinical Research Organisations.
  • Support the local organisation in the preparation for, conduct of and responses to audits and regulatory inspections.
  • Advice Local Study Delivery Teams in the resolution of the findings in local audit reports issued by CQA.
  • Support the Clinical Research teams (e.g. Study Delivery Teams, Clinical Project Teams) in the resolution of issues found in inspections.
  • Contribute to development and maintenance of global Clinical Development procedures
  • Participate in the Clinical Process Managers’ Network
  • Keep up to date knowledge of local regulations
  • Keep a network local ICH/GCP specialists
  • Give regular feedback on CQA findings to relevant MC/CRR staff.

Qualifications and Experience

  • Education

             - University Degree

  • Experiences

             - 5 years or more of relevant experience with clinical research

             - Good ability to learn and to adopt to work with IT systems.

Skills and Knowledge

  • Functional skills

              - Good knowledge of AZ Procedural Documents

              - Excellent knowledge of international guidelines ICH/GCP

              - Excellent knowledge of relevant local regulations

              - Good understanding of the Drug Development Process

              - Excellent knowledge in Clinical Development

              - Excellent understanding of the Clinical Study Process

              - Good knowledge/experience of the Monitoring Process

              - Good understanding of the Study Drug Handling Process

              - Good understanding of the Data Management Process

              - Good project management skills

              - Good coaching skills.

  • Other skills

              - Good computer skill

              - Good planning skill

              - Good problem-solving

              - Good negotiation skill

              - Good interpersonal skills and teamwork

              - Good communication and presentation skill

              - Good organisational skill

              - Basic training skill

              - Good knowledge of spoken and written in English

CPrM (Clinical Process Manager)

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