Sr. Executive / Asst. Manager - Clinical Trials management

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