- 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
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