Manage and execute multiple global clinical trials across various therapeutic areas including overseeing the entire lifecycle of clinical studies, from site selection and initiation to monitoring and close-out. Conducting regular site visits to ensure compliance with study protocols, SOPs, GCP, and regulatory requirements. Experienced in Internal Quality Visits and Sponsor Oversight Visits, which involved evaluating site performance and ensuring adherence to quality standards. Gained extensive experience in managing the Database Lock process, ensuring data integrity and accuracy before the final database lock. Being responsible for managing site performance, resolving issues, and ensuring high data quality through rigorous monitoring and verification. The role required effective communication and collaboration with cross-functional teams and stakeholders, contributing to the successful delivery of research projects on time and within budget.

Ensure compliance with standard protocol and regulatory and ICH GCP obligations in assigned aspects of clinical site monitoring, such as site initiation, routine monitoring, maintenance of study files, study close out, and retrieval of study materialsComplete on-site and remote monitoring activities in compliance with the Clinical Monitoring Plan, including source document verification, as requiredEnsure the integrity of data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations, and internal SOPsWrite and submit reports of investigational site findings and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriateManage essential documents as required by local regulations and ICH GCP before, during, and after a clinical study; assist with resolution of investigational site/data queries

Monitoring and providing site management oversight for assigned clinical trials (phase I-II-III) according to ICH-GCP guidelines, FDA regulations, protocol and sponsor SOPs.Reviewing and approving monitoring reports, tracks ongoing issues and query resolution.Coordinating activities such as study design, protocol preparation, informed consent preparation, CRF design and other activities to ensure on time completion of studies.Preparing Regulatory Authority and Ethics Committee submissions and follow-up approval letters in coordination with CTA.

Conducting clinical phase II-III-IV studies in the field, communicating with the principal investigator and the sponsor, site initiation visit, monitoring visits, AE/SAE notification

To verify that the conduct of the study is in compliance with the currently approved amendments with GCPCommunication with the medical site staff including coordinators, clinical research physicians, and their site staffVerification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol.