Sourav Mandal

Clinical Research Coordinator @Clinimed Lifesciences

Kolkata, IN

Collaborations with internal and external stakeholders and cross-functional team collaboration. Managed study start up, Site feasibility and/or site selection process, protocol adherence, and site management to ensure compliance with study protocols. Managed adverse event (AE) and serious adverse event (SAE) reporting processes, ensuring timely and accurate documentation. Involvement in Regulatory Compliance audit/inspection process. Submission of EC dossier to EC of the site and follow-up for approval, Coordinating EC Committee. Equipment calibration and tracking. Knowledge of clinical trial management systems (CTMS). Managed collection and entry of clinical trial data into the EDC system, ensuring optimum accuracy. Managed over 3 global oncology trials with patient recruitment success rates of 95% and Coordinated 10+ phase I, II IV, and BA/BE clinical trials for oncology drugs,