Associate Director Clinical Research

[Job description]

The Associate Director Clinical Research (ADCR) is responsible for delivering the committed part of all clinical interventional studies under their supervision according to agreed resources, and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. The ADCR is responsible for line managing dedicated group(s) of staff such as Clinical Research Associates (CRAs) and/or Clinical Study Administrators (CSAs) and is responsible for planning and utilization of staff resources, objective setting and performance follow-up. As assigned, the ADCR is responsible for ensuring that study sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived, as agreed locally. In some countries a ADCR may also take responsibilities as Local Study Associate Director (LSAD) if required and agreed with the (Senior) Director, Country Head.

[Typical Accountabilities]

• Leadership of dedicated group, building the team spirit, developing team style and behaviour.
• Ensures adequate resources for the studies assigned.
• Ensures that the workload of direct reports is adequate.
• Development and performance management of direct reports.
• Ensures that direct reports have development and training plans, according to IDP process.
• Coaches the direct reports on a regular basis, and plans/organises coaching with external providers if needed.
• Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with responsible (Senior) Director, Country Head and local HRBP.
• Contributes to efficient SMM organisation and its functioning at country level by working closely with responsible (Senior) Director, Country Head.
• Contributes to high quality feasibility work.
• Supports successful delivery of SMM study delivery country level targets to plan, with speed and quality.
• Contributes to the quality improvement of the study processes and other procedures.
• Ensures all systems are continuously updated.
• Ensures completeness and timeliness of the eTMF to maintain it “Inspection Ready”.
• Provides direction to CRAs and CSAs on major study commitments including resolving any key issues identified.
• Ensures that study activities at country level comply with local policies and code of ethics.
• Reviews monitoring visit reports of direct reports in line with AZ SOPs
• Reviews Accompanied site visits/co- monitoring visits/training visits/QC visits performed to direct reports in line with the local QC plans.
• Performs accompanied site visits according to local QC Plan, supporting ongoing coaching and development. Ongoing communication with Functional Service Providers, including directions and feedback on insourced/outsourced work

[Skills]

• 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 Associate Director Clinical Research (ADCR)을 채용하오니 많은 지원 바랍니다.

※ 채용 절차법에 따른 고지 사항

1. 전자우편으로제출한서류는채용절차법에따라, 일체반환의무가없습니다.

2. 보훈대상자 및 취업보호대상자는관련법에의거하여우대합니다.

3. 해외여행결격사유가없어야합니다.

4. 본 채용은수시진행으로, 우수인력채용 시 마감될 수 있습니다.

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 authorisation and employment eligibility verification requirements.