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In large complex trials the Associate Clinical Trial Physician helps the Clinical Trial Phyician to maintain the reliable, high quality real time medical oversight.
Key Accountabilities/Responsibilities
- Real time Medical Monitoring of clinical studies according to the directives of the Global Clinical Trial Physician : ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early . Pro-active escalation and suggested corrections for issues to the Trial Physician
- As delegated by the Global Clinical Trial Physician: may contribute to review of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trials
- Ensures study compliance for all medical aspects delegated to him/her by understanding and applying all relevant SOPs and GCPs
- Closely collaborate with the cross functional study team members in order for medical risks, issues, and results to be clear to all involved parties
Desired Skills And Experience
- Medical Doctor; relevant specialty education preferred
- Excellent English, both written and spoken is a must.
- Pro-active problem solver with negotiation skills , with good judgement concerning escalation of issues
- Strong communication skills to ensure close collaboration with the cross functional team members