Associate Director Clinical Research, Country Feasibility Lead (Biopharmac)

Job Description

• Awareness into study/program Pipeline to support evaluation of country strategy (e.g. upcoming feasibilities)
• Attendance of Global Country Feasibility Network sessions (e.g. updates & lessons learned)
• Support of country specific operational input into Feasibility strategy phase (e.g. country specific experience and considerations)
• Supporting and providing input to feasibility site survey/interview guide
• First point of contact for feasibility related questions within country, responsible for triaging questions/invitations/materials out locally
• Review of Feasibility materials prior to key meetings
• Review and consolidation of local site list; by utilizing global site list, collecting input from Medical Affairs and other relevant site intelligence tools
• Country specific input to early recruitment modelling scenario planning (e.g. start-up, site activation)
• Coordinating Site level Feasibility activities by identifying and connecting with appropriate potential sites/investigators utilizing AZ systems
• Contacting selected investigators and follows up to collect feedback on study design concept/protocol
• Review of country specific feedback with country head prior to provision to Global SMM (Country recruitment commitment and operational concerns)
• Initiating a Study Handover to LSAD after preliminary allocation (e.g. supporting tailoring local SQV material based of material from Global Study Team)
• Supporting the site selection process post feasibility by identifying potential sites/investigators based on feasibility feedback
• Supporting the local team with early milestones as part of VCV baselining (e.g. from early scenario model). Also, 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.  

Skills

• Good knowledge of the Clinical Study Process and international ICH-GCP guidelines.
• Excellent knowledge of the Feasibility and Monitoring 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.

Qualifications

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

※ 채용 절차법에 따른 고지 사항

1. 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.

>>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.

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.