
工作职责:
Responsibilities:
1. Be responsible for the progress, deliverables and quality of Data Management (DM) work for one or more clinical trials with role of DM project manager.
2. Custom facing.
3. Collaborate with other functions either within the company or outside in the conduct of clinical trials, representing DM and provide strong DM expertise in study team.
4. Provide comprehensive DM guidance to study team as well as junior college. Be able to provide solutions to resolve issues. When needed, do DM hands-on work include but not limited to DMP, CRF design, CRF completion guideline, Edit check specification, medical coding, SAE reconciliation etc.
5. Compliance with GCP, regulations, company and/or sponsor SOPs. Ensure the inspection readiness of DM work.
6. May perform study lead role or people manager role.
7. May perform Subject Matter Expert role.
任职资格:
Requirements:
1. Experience of leading full scope of DM work throughout the study independently.
2. Comprehensive DM knowledge and experience.
3. Excellent project management, communication, multi-task management skills,
4. Experience and knowledge of EDC system, CDISC standards include but not limited to CDASH, SDTM, define etc..
5. Understand medical and pharmaceutical terms and have TA knowledge.
6. Education: Bachelor or Master Degree in Medicine, Pharmacology, Statistics, Mathematics and other medical or data management related majors.
7. Familiar with MS office; familiar with SAS software.
8. Work independently, good at learning, with a proactive attitude. Capable to work under pressure.
9. Excellent in Oral and writing English