[글로벌 유명 제약사] 임상시험 study start up /신입가능

[기업 소개]

외국계 유명 제약사

[업무 내용]

JOB PURPOSE/PRIORITIES:
The Study Start-up (SSU) Associate functions as a subject matter expert on all SSU-related activities in the country, conducts SSU activities in collaboration with other clinical research stakeholders
Provision of updated information regarding the regulatory environment and trends that could impact positively or negatively the approval processes, mainly those related to timelines for approval to the study team(s), CSU and investigators if appropriate.

- Study Start-up Coordination and Execution: Coordinates, guides and assists with all start up activities prior to site activation, including but not limited to:
Ethics Committee information, meeting dates & costs
Ethics applications & associated online systems
Ethics & Governance submission processes
Contracts & Indemnity request process
Communication/collaboration with sites and study teamfor successful contract execution
- Maintain up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation
- Review, analyze and collate metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation
Ensure all start up information & requirements are kept up to date in a central repository for project teams

[근무조건]

- 기간:  파견 계약직 1년 (이후 연장 가능)

- 급여: 경력에 따라 협의 / 희망급여 제시

- 지역: 서울시 강남구 3호선 / 7호선 고속터미널역 인근

- 시간: 평일 9시 ~ 18시

- 기타: 4대보험 가입, 연차휴가, 퇴직금, 경조금 , 경조휴가 , 명절선물 , 생일자 상품권등  지급 등 내규에 따름

[지격 조건]

-Prior work experience demonstrating knowledge and understanding of clinical trials, such as that obtained in a clinical trial monitor capacity, and experience managing projects

-Demonstrated Knowledge and understanding of ICH-GCP, the regulatory, ethics and contractual requirements for starting clinical trials in relevant country

-Be able to communicate efficiently on different levels, be assertive and can work on several projects at once with high flexibility, be detail oriented and have excellent time management and organizational skills

-Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe

-Self-motivation with the ability to work under pressure to meet deadlines, works well independently as well as in a team environment

지원방법]
- 메일접수시 제목에 외국계 제약사 _  ssu   _성함` 기재 바랍니다.
** 적합자 지원시 서류전형 조기마감 되실 수 있으므로, 빠른 이력서 접수 부탁 드립니다.

[담당자]
김민경 차장 760-8863 / mk.kim@kellyservices.kr

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