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[Dept. & Job
Title]
Medical Operation(CR)Associate, Medical
Affairs
[PURPOSE OF
POSITION/ROLE]
Support Local Clinical
Trials
(Interventional Phase IV non-registration study, Non-Interventional
Study including and Post Marketing Surveillance)
[Activities &
responsibilities]
- Plan, set-up, monitor and coordinate
clinical trials to the required standards of GCP and the company
- Tracking
the progress of a clinical trial to ensure it is conducted, recorded and
reported in accordance with the protocol, SOPs, ICH GCP, applicable regulatory
requirements and within the given budget
- To help ensure clinical trials are
reported in a timely manner conducive to rapid marketing authorisation
application and/or submission to a peer reviewed journal
- Initiate the
ProtocolDevelopment and Start-up Activities in collaboration with the corporate
and the outsourced CRO
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