00强欧美制药和Golbal CRO公司招聘信息
岗位名称
1.Clinical Submission Specialist
City: Beijing Wuhan shanghai Tianjin Zhengzhou Xi an Qingdao Shenyang Dalian Liaoning
Ha er bin Jilin Bianyan
Duties and Responsibilities (according to relevant guidelines, laws and SOPs):
1. Ensure ongoing awareness of EC/CA submission deadlines, meeting dates and procedures and communicate to start up team members as appropriate.
2. Arrange payment of EC/CA fees.
3. Work with start up CRA(s) to ensure the essential documents are in place to obtain regulatory, ethics and provincial application approvals within agreed timelines.
4. Liaise with the CRAM to prepare and submit regulatory, ethics committee and provincial applications and regulatory packages.
5. Liaise with the CRAM to prepare and submit special national or local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license, etc.
6. Liaise with regulatory authorities, ethics committees and investigators where applicable, to facilitate and ensure EC/CA applications are managed in a timely manner.
7. Coordinate responses to any EC/CA questions in a timely manner as required.
8. Report on progress to CRAM and project team for CA/EC application status.
9. Work with the start up CRA (s) to prepare the regulatory compliance review packages.
10. Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
11. Maintain a working knowledge of ICH/GCP, SOPs WPDs and applicable client SOPs.
12. Liaise and inform CRA(s) of EC/CA progress and site communication throughout the life cycle of the project.
13. Enter and maintain trial status information relating to start-up activities onto tracking databases ( e.g. CASCADE & Pulse )in an accurate and timely manner.
14. Support the coordination of feasibility activities, as required, in accordance with agreed timelines.
15. Liaise with other departments as required.
16. Liaise with the CRAM to prepare and submit regulatory, ethics committee and provincial application amendments throughout the life cycle of the study.
17. Sharing of ideas and suggestions with team members ensuring effective communication within the Start-up Team.
18. Facilitate and respond to company, client and regulatory audits where required.
Qualifications:
A degree in a science related field or equivalent by experience is required
Skills and Knowledge:
· Effective oral and written communication skills
· Excellent interpersonal skills
· Strong attention to detail
· Good computer skills and the ability to learn appropriate software
· Good English language and grammar skills
· Basic medical/therapeutic area and medical terminology knowledge
· Ability to work in a team or independently as required
Experience:
Experience with handling of EC/CA applications is desired as well as a good working knowledge of ICH/GCP, SOPs, WPDs and applicable client SOPs.
2. CRA
City：beijing shanghai wuhan
Main job activities/tasks
Study Planning/set-up activities