Dr. Sandeep Soni, PhD

• Centralized Monitoring Lead (CML) partners with the Clinical Lead (CL) and local country Site Monitors in project execution. The CML provides centralized support and contributes to site management for a variety of protocols, sites and therapeutic areas. CML supports study start-up, manages resource requests, performs ongoing clinical risk assessment through data trending and analytics and proposes potential mitigating actions in a timely fashion. CMLs are also involved in the Investigators payment process. • Experienced in CRA trip report reviewing. Well experienced and knowledge in reviewing the reports in CTMS, good knowledge in CTMS application handling. • Experience in TMF review and processing • Analytical Approach: • Generate and review weekly/monthly reports and perform data mining and raw data analysis to identify risks upfront and propose mitigation plans. • Establish and maintain a Question and Answer Log to track ongoing protocol and project questions/issues • Manage oversight for COP compliance in consultation with CL. • CMLs have oversight on protocol deviation tracking and will need to check that the Monitors follow the relevant SOPs and Sponsor guidelines. • Audit readiness: Prepare the sites/CRA for audit ready all time. Quality management plan need to be updated and checked with the QA team. Perform RCA and analyze the mitigation plan to help the CRA to prepare and submit the CAPA before timelines. • Handle customer complaints and analyze the RCA to complete the loop in finalizing. • Review on a daily basis any new Project Alerts on the Infosario Alert Dashboard and complete any actions that may be required. • Track and follow-up with Monitor on non-recruiting sites and propose mitigation action. Follow appropriate escalation processes, including zero enrolment letter and site closure, as agreed per project. Support CL to revise project recruitment strategies as needed.