[Biopharma] Study Start-Up Manager

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 분리되어, 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 정규직Study Start up Manager (SSUM) 을 채용하오니 많은 지원 바랍니다.

[Role description]

The Study Start-Up Manager (SSU Manager) is responsible at country level for managing and conducting start-up activities in compliance with the AZ procedures, documents, local and international guidelines such as ICH – GCP and relevant regulations.

The SSU Manager will prepare, review, track and manage site regulatory documentation at country and site level, and will maintain, review and report on site performance metrics.

The SSU manager works in close collaboration with the CRAs and the Local Study Team/Local Study Associate Director to ensure that study start-up activities and milestones are achieved in a timely and efficient manner.

SSU Manager might have different internal titles based on the experience level (SSU Manager, Senior SSU Manager). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The Director, Country Head may assign this internal title after confirmation with Senior Director, Cluster Head / Executive Director, Regional Head. 

[Typical Accountabilities]

• Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality.

• Accountable for study start-up and regulatory maintenance being in charge with collection, preparation, review and tracking of documents for the application process;

• Accountable for submission of proper application/documents to Regulatory Authorities and/or IEC/IRB during start-up period.

• Actively participates in Local Study Team (LST) meetings.

• Update CTMS and other systems with data from study sites as per required timelines during the start-up period.

• Follow up on outstanding actions with study sites during start-up period to ensure resolution in a timely manner.

• Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements. Support QC checks performed by LSAD or delegate to ensure that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with AZ SOPs.

• Provide regular information to Line Managers at country level on study and planned study milestones/key issues during the start-up period.

• Provide feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.

• Support SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.

Upon local decision, additional responsibilities may include*:

• Prepare, review and negotiate contracts with investigational sites being the primary point of contact for investigational sites to ensure the contracts are fully executed 

• Support site selection process by identifying and assessing potential sites/investigators

• Accountable for continuing submission of proper application/documents to IEC/IRB and to Regulatory Authorities for the duration of the study.

• Assist in initial forecasting for budget, study materials and drug supplies. Plan applicable local drug activities (local purchase or reimbursement)

*Note: Additional responsibilities may be adjusted locally.

[Essential]

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification.

• Good knowledge of international guidelines ICH-GCP as well as relevant local regulations, basic knowledge of GMP/GDP

• Basic understanding of drug development process

• Good collaboration and interpersonal skills.

• Good verbal and written communication skills.

• Excellent attention to details.

• Excellent understanding of Clinical Study Management and study start-up

• Good negotiation skills.

• Good ability to learn and to adapt to work with IT systems.

[Desirable]

• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.

• Integrity and high ethical standards.

• Good analytical and problem-solving skills.

• Good financial management skills.

• Basic change management skills.

• Good intercultural awareness.

• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.

• Good analytical and problem-solving skills.

• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.

• Good cultural awareness.

• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.

※ 채용 절차법에 따른 고지 사항

1. 전자우편으로 제출한 서류는 채용 절차법에 따라, 일체 반환 의무가 없습니다.

2. 보훈대상자 및 취업보호대상자는 관련법에 의거하여 우대합니다.

3. 해외 여행 결격사유가 없어야 합니다.

4. 본 채용은 수시진행으로, 우수인력 채용 시 마감될 수 있습니다.