Study Start-up (SSU) Associate

Position title: Study Start-up (SSU) Associate 
근무형태 :파견계약직(1년)
지원 방법: 이메일 recruitment.kr@sanofi.com
*사람인으로 지원하시더라도 이메일로 본인의 영문이력서(resume), 국문이력서/자기소개서 보내주시길 바랍니다.

[Purpose]
-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 appropriate input and support for all the regulatory activities. 
-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. 


[Responsibilities]
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
- Clinical Trial Health Authority application and regulatory submission process: Prepare the regulatory package in collaboration with Regulatory Affairs department according to the local requirements. 
- Submit the Regulatory package to the IRB / IEC when it is appropriate and/or to the Health authorities either in parallel or in sequential way according to the local regulations. 
- Concentrate communications and answer questions, inquiries from the Regulatory / Health authorities after discussion with the appropriate functions (i.e. Clinical Project Leader, Medical Advisor, Regulatory Affairs..)
- Be the liaison between the CSU and the Affiliate Regulatory Department 
- Contracts & Indemnity request process
- Work together with sites and appropriate legal departments for 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.

[Requirement]
-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
-Good command of English (written and spoken)
-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