Complete project management of global as well as domestic clinical trials ensuring compliance with contract and defined quality standards, Protocol, SOPs, GCP and applicable regulatory requirements.

- Conduct Site selection, activation, routing monitoring and close outs visits and overall management of assigned sites. - Keep close association with the investigative sites for tracking and monitor the enrolment, timely completion of CRFs, DCFs, clinical study material supply to the sites, AE and SAE management, source data collection and any trouble shooting at all investigative sites. - Ensure communication with sites for ethics committee notifications of Serious Adverse Events, Study Progress, Protocol Deviations, Safety Reporting etc., as applicable. - Conduct on-site routine clinical monitoring which includes: document review, ensuring accurate data recording, verifying patient data, IP Accountability, adherence to the Clinical study protocol, GCP guidelines, regulatory and applicable quality standards.

- Participated in more than 20 clinical trials including First in Men device, phase II, III and IV/PMS studies of Anti-platelet, Antithrombotic, cardiovascular drugs and devices, stem cell therapy etc.- Involved on site management activities including mentoring and training of study coordinators.- Managed multiple studies at a time and provided quality deliverables in desired time-frames. - Faced multiple monitoring and sponsor’s audit