· Prepares/Reviews CDP, IB, study protocols, ICF, scientific advices, TLFs and CSRs.
· Attends standing meetings of boards, committees, etc. as and when required.
· Provides/Reviews medical inputs for study conduct as per applicable GCP, SOP and regulatory requirements .
· Provides inputs on study level data including GCP-issues report.
· Attends regular meetings with CRO and/or other vendors.