Associate Director Clinical Research, Country Feasibility Lead (SMM Biopharmaceuticals)
๐ฐ๐ท South Korea
Management
GCP
Design
Recruitment
Associate Director Clinical Research, Country Feasibility Lead (SMM Biopharmaceuticals)
from ๐ฐ๐ท South Korea
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.ย ย
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 โ 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
โป ์ฑ์ฉ ์ ์ฐจ๋ฒ์ ๋ฐ๋ฅธ ๊ณ ์ง ์ฌํญ
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4. ๋ณธ์ฑ์ฉ์์์์งํ์ผ๋ก,์ฐ์์ธ๋ ฅ์ฑ์ฉ ์๋ง๊ฐ๋ ์์์ต๋๋ค.
>>์์คํธ๋ผ์ ๋ค์นด์SMM (Site Management & Monitoring)๋ถ์๋ ์์คํธ๋ผ์ ๋ค์นด ๋ณธ์ฌ์ ์ฐ๊ตฌ๊ฐ๋ฐ ์ฐํ์ ์๋ ์์์ํ ์ํ๋ถ์๋ก์,๊ฐ ๋๋ผ์์ ํด๋น ์์์ํ์ด ์ ์ํ๋ ์ ์๋๋ก ๊ด๋ฆฌํฉ๋๋ค.์์คํธ๋ผ์ ๋ค์นด์SMM๋ถ์๋ ๊ธ๋ก๋ฒ ๋ณธ์ฌ์ ์น๋ฃ๋ถ์ผ์ ๋ค๊ฐํ ์ ๋ต์ ๋ฐ๋ผ ํญ์์ ๋ถ์ผ์ ๋น-ํญ์์ ๋ถ์ผ๋ก ๋ถ์๋ฅผ ๋ถ๋ฆฌํ์์ผ๋ฉฐ,์ด์ ์ต๊ทผ ํ๊ตญ ์์คํธ๋ผ์ ๋ค์นดSMM๋ถ์ ์ญ์ ๋๊ฐ๋ก ๋ถ๋ฆฌ๋์์ผ๋ฉฐ,๋น-ํญ์์ ๋ถ์ผ๋SMM BioPharma๋ผ๋ ์ด๋ฆ์ผ๋ก ์๋ก์ด ๋ฆฌ๋์ญํ๊ณผ ํจ๊ป2023๋ ์ ์ถ๋ฒํ์์ต๋๋ค.ํ๊ตญ ์์คํธ๋ผ์ ๋ค์นดSMM BioPharma๋ถ์๋,๋น-ํญ์์ ๋ถ์ผ์ ํ์ดํ๋ผ์ธ ํ์ฅ์ ์ง์ํ๊ธฐ ์ํด ํ์ฌ ์๋ก์ด ์ฐ๊ตฌ๋ฅผ ํ๊ตญ์ ์ ์นํ๊ณ ์ํํ๊ธฐ ์ํด ๋ง์ ์ธ๋ ฅ์ด ํ์ํ๋ฉฐ,์์ผ๋ก์ ์ฑ์ฅ๊ณผ ๋ฐ์ ์ด ๊ธฐ๋๋๋ ์กฐ์ง์ ๋๋ค.๋ฏธ๋๊ฐ ๋์ฑ ๊ธฐ๋๋๋ ํ๊ตญ ์์คํธ๋ผ์ ๋ค์นดSMM BioPharma๋ถ์์์ ์์์ํ์ ๋ฌธ๊ฐ๋ก ์ฑ์ฅํ ์ ๊ท์งStudy Start-Up Associate Director (SSU-AD)๋ฅผ์ฑ์ฉํ์ค๋ ๋ง์ ์ง์ ๋ฐ๋๋๋ค.
Date Posted
21-6์-2026Closing Date
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