Job Description: • Scientific review of Protocol and related documents i.e ICF, CRF, Plans, logs and forms, etc. as per regulatory requirements. • Review of SIV presentations prepared by CRO and check for its compliance with protocol and applicable regulatory requirements. • Should have knowledge of various EDC platforms and can do review of eCRF for edit checks. • Accompany CRO personnel for SIV and resolve all queries raised during SIV for smooth execution of the study. • Tracking patient recruitment and pushing the CRO for timely delivery of the project. • Oversight monitoring of the study data across all sites. • Resolved all issues identified during the monitoring visit after discussion with CRO to best of interest of the study. • Track and process on CRO’s payment as per defined milestone in agreement. • Accompany CRO personnel for closeout visit and resolve all outstanding queries raised during monitoring visit. • Should have experience in handling patient PK and CEP study for regulated market i.e USFDA, EU, Canada • Scientific review of Clinical Study Report. M. Pharm (Clinical Pharmacy/Pharmacology) 5-7 years' Experience