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KNOWLEDGE, SKILL, FORMAL EDUCATION & EXPERIENCE REQUIREMENTS
A. Knowledge And Skills:
Medical and Scientific expertise.
High level of autonomy, motivation, good communication skills as well as team player
Autonomous, proactive, able to drive an activity until final deliverable
Self-motivated & results oriented with attention to detail
Quality focused and well organized
B. Formal Education And Experience Required:
Medical educational background with M.D. or Master or PhD degree
Physician with clinical practice experience in hospitals at least 1 year
Prior to consider previous medical validation/review experience in Clinical Research and/or
Clinical DrugDevelopment (e.g., at least 1 year within pharma industry or CRO)
Knowledge in ICH, GCP
Fluent in English (spoken and written)
C. Knowledge And Skills Desirable But Not Essential:
Technical: knowledge in reporting tools and technics
PRINCIPAL DUTIES AND RESPONSIBILITIES
1. Conduct medical validation/review tasks directly
2. Conduct medical validation/review according to compound safety profile, study population characteristics,
study design and efficacy criteria
3. Review/comment/provide input at Medical Validation KOM, Medical review plan KOM. Participate in update
of MVP/MRP base on new information during course of study conduct
4. Set up /schedule medical review resolution meetings with CSDs (GSOs ad hoc), Schedule CIOMS/PP
review reconciliation meetings with CSDs (CTOMs or CMEs ad hoc)
5. Working with Team Leader, taking into account CSDs’ perspective on the task allocated. Define priorities
for the allocated tasks
6. Interact with Team Leader regularly on tasks advancement and completion, difficulties encountered, and
potential delays
7. Define timelines for completion of each task, in coordination with team Leader and CSDs
8. Proactively communicate with other functions (eg TO, GPE, CSU, CDOC, TIM (BICC) and so on) to
resolve safety data issues timely and effectively