Study Start-Up Associate Director

[Role description]

The Study Start-Up Associate Director (SSU AD) is responsible at country level for organizing, overseeing and control the start-up component of the clinical trials conducted internally by SMM according to agreed resources and schedules in compliance with the AZ procedures, documents, local and international guidelines such as ICH – GCP and relevant regulations. The SSU AD will oversee and provide direction for submission to Regulatory authorities and/or Ethics Committee, and any other start-up related activities agreed locally. The SSU AD will ensure continuous SSU process improvement and establish high quality standards across all AZ internally managed studies.

[Typical Accountabilities]

• Ensure adequate resource planning for new work across TAs allocated to local SMM to enable timely allocation of staff during start-up period.
• Ensure performance development of the SSU team (SSU Managers and CSAs)
• Ensure ongoing coaching and development of SSU team
• Supporting LSADs and Local Study Teams with conducting regulatory submission & following up on approvals and other country level SSU activities during start-up phase of the study.
• Support SMM region in initiatives/activities, as appropriate
• Ensure that study activities undertaken by the SSU team at country level comply with local policies,regulations & code of ethics
• Ensure project oversight of all studies through to site activation for purposes of SSU team resourcing.
• Provide direction to LSADs/SSU team members on ways of working during start up including resolving SSU process issues as identified.
• Is a point of escalation to support resolution for any complex issues with study start up activities.
• Is the Local process owner for study start up, ensuring maintenance of guidelines, templates and other applicable procedural documents and process improvement
• Has excellent understanding of the local clinical trial environment, working externally to influence and improve start-up process.

* Note: Some accountabilities above may also be shared with SMM Directors. Upon local decision, additional responsibilities may include*:

• Assist LSADs in forecasting study timelines.
• Ensure or support project oversight for studies during their entire lifecycle
• Oversight of local feasibility process through to country selection including ensuring robust processes are in place for conducting feasibilities into Biopharma studies.

* Note: Additional responsibilities may be adjusted locally.

[ Skills ]

• Minimum 2 years in Study Start-up experience
• Good knowledge of the Clinical Study Process.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 and international regulations.
• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
• 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.
• Ability to work in an environment of remote collaborators.
• Integrity and high ethical standards.
• Good resource management skills.
• Excellent decision-making skills.
• Good conflict management skills and ability to handle crisis.
• Good interviewing skills – responsibility for attracting, developing and retaining personnel.
• Excellent team building skills.
• Good intercultural awareness.
• Excellent ability to work according to global standards.

[ Qualifications ]

• Education: BSc
• Language: Korean and English
• Certifications: GCP
• Work Experience: More than 5 years
• Competencies: Line Management Experience for CRAs

아스트라제네카의 SMM (Site Management & Monitoring) 부서는 아스트라제네카 본사의 연구개발 산하에 있는 임상시험 수행부서로서, 각 나라에서 해당 임상시험이 잘 수행될 수 있도록 관리합니다. 아스트라제네카의 SMM 부서는 글로벌 본사의 치료분야의 다각화 전략에 따라 항암제 분야와 비-항암제 분야로 부서를 분리하였으며, 이에 최근 한국 아스트라제네카 SMM 부서 역시 두개로 분리되었으며, 비-항암제 분야는 SMM BioPharma 라는 이름으로 새로운 리더십팀과 함께 2023년에 출범하였습니다. 한국 아스트라제네카 SMM BioPharma 부서는, 비-항암제 분야의 파이프라인 확장을 지원하기 위해 현재 새로운 연구를 한국에 유치하고 수행하기 위해 많은 인력이 필요하며, 앞으로의 성장과 발전이 기대되는 조직입니다. 미래가 더욱 기대되는 한국 아스트라제네카 SMM BioPharma 부서에서 임상시험전문가로 성장할 정규직 Study Start-Up Associate Director (SSU-AD)를 채용하오니 많은 지원 바랍니다.

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