Narayan Sule Email & Phone Number

Mumbai, Maharashtra, India

Job Responsibilities :- •To monitor the clinical phase of BA/BE / Clinical Trial Studies In compliance with ICH-GCP, SOPs and applicable local Regulatory Guidelines and within timelines.• Checking of Calibration and validation reports of instrument.• Monitoring the activities like screenings, check-in, dosing, check-out and all study activities.• Conducts quality control reviews in order to assure that documentation of Clinical projects are of the Highest standard and in Compliance with the Requirements of the SOPs, Study Protocols and Good Clinical Practice.• Review various Clinical Study Report .• checking of CRF, ICF , Screening consents, Study Master File.• Reviewing of check-in day activity, Dosing day activity and all study related activities.• Checking Protocol Deviation/ Violation and Corrective Action and Preventive Action (CAPA).• To supervise BA/BE/Clinical Trials Project Activity and co-ordinate with other departments till completion as per committed timelines and oversee the documentation.• Responsible for Subject monitoring, AE Management , Maintain Safety Parameters.• Responsible for supervision of Vital signs and Blood Sample collection in CPU Unit.• Responsible for supervision of centrifugation, separation of sample and their storage during study.• To supervise sample dispatch to Bioanalytical Department and to external facility.• Ensure the execution of good clinical practices and safety procedures. • Checking of volunteer data sheets and pathology report. • Any other assignment allocated by head operations / Clinical Research Manager.

Navi Mumbai, Maharashtra, India

Job responsibilities: -• To monitor the clinical phase of BA/BE / Clinical Trial Studies In compliance with ICH-GCP, SOPs and applicable local Regulatory Guidelines and within timelines.• Conducts quality control reviews in order to assure that documentation of Clinical projects are of the Highest standard and in Compliance with the Requirements of the SOPs, Study Protocols and Good Clinical Practice.• Review various submission reports (CSR) to regulatories Like DCGI, USFDA, EMA ,ANVISA etc. • Reviewing Statistical Reports.• Checking eCTD (Module 5)• Checking of Bioclinical data like eCRF, eMSR, ICF and Raw Data etc. In BizNET software.• Checking of volunteer screening Activities in BizNET Software.• Reviewing of check-in day activity, Dosing day activity and all study related activities.• Checking Bioclinical data like CRFs , MSR, ICF , TMF and Raw Data etc.• Checking of Note To File (NTF) , Protocol Deviation/ Violation and Corrective Action and Preventive Action (CAPA).• To supervise BA/BE/Clinical Trials Project Activity and co-ordinate with other departments till completion as per committed timelines and oversee the documentation and completion .• Responsible for Subject monitoring, AE Management , Maintain Safety Parameters.• Responsible for supervision of Blood Sample collection in CPU Unit.• Responsible for supervision of centrifugation and separation of sample and their storage during study.• To supervise sample dispatch to Bioanalytical Department and to external facility.• Ensure the execution of good clinical practices and safety procedures. • Checking of volunteer data sheets and pathology report. • Any other assignment allocated by head operations /section head quality control.