Manager Clinical Trial

You should have a qualification of M.B.B.S/M.D/M.Sc/M. Pharm/Ph.D. with 8-10 years of experience. As a professional in this role, your responsibilities will include: - Preparing and reviewing synopsis for bio study protocol. - Finalizing protocols based on the synopsis and SOP requirements. - Coordinating with IEC and Voxtur for protocol approval. - Reviewing clinical study reports to ensure compliance with regulatory requirements. - Incorporating suggestions from study director, investigators, and sponsors into the report. - Submitting clinical summary updates/reports to IEC. - Ensuring timely start, smooth conduct, and timely completion of the clinical phase of studies across various locations. - Assisting in the development of SOPs, providing training to the internal team, facilitating site identification, and conducting site visits. - Providing medical inputs to the study team. - Conducting quality monitoring visits on site with CRAs to ensure protocol and regulatory compliance. - Following up with investigators regularly. - Coordinating with vendors involved in the study for various activities. - Reordering trial site supplies and trial medication as needed. - Maintaining appropriate documentation of trials in accordance with GCP. - Negotiating CTAs and providing initial approval for finance and budgeting.,