Akash Wadhe

Clinical Research Associate-i @KlinEra Global Services

Mumbai, IN

1) To perform global site management activities in compliance to Protocol, SOPs, Guidelines and Regulations.2) To manage the Finance reconciliation during the course of the study.3)To provide various study related updates in a timely manner to project manager.4)To support DM and MW with respect to smooth completion of the study.6) To manage SAEs/AEs reporting in compliance to SOPs and regulations.07)To complete enrollment of patients and clinical initiation of studies as per agreed timelines with management08)To plan site visits ensuring completion of all pending activities at site i.e. 100% CRF collection, IMP and Finance reconciliation, SSF review.09) To support QA for the planned Audit and regulatory Inspection compliance. Zero Critical findings during Audit / Inspection. Ensure timely response and closure with robust CAPA to the Auditor and Inspector.