Vivek Desai

About Vivek Desai

16 years of experience (Clinical data management) department. Worked…

Experience

1. Senior Clinical Data Manager Ii

   AstraZeneca

   Oct 2021 — Present

   Study level CDM administrative support based on the relevant model and DM Vendor. This related to the study start up, conduct and closeout phases.(i.e, Documentation review and/or creation, User Access Testing, query management, data cleaning and reviews, third party data reconciliation in accordance with the project study model, KPIs and project timelines.• Day to day responsibilities may include o Study status reporting to the relevant clinical study team members,(e.g, provide data to clinical teams for performing medical and clinical reviews, coordination of instream data review, lab data review, etc.)o Collaboration with Data Management Vendor regarding upcoming deliverables and milestone achievements (i.e, snapshots, interim, and migrations). o Oversight of the data quality, documentation quality, and types of these deliverables and milestones.• Assist with coordination CDM deliverables on assigned projects depending on the relevant model and DM Vendor.• Oversight of the day-to-day operational aspects of CDM for assigned studies; Responsible to identify risks and collaborate with the Principle Clinical Study Data Manager to mitigate the risk.• Understands therapeutic area, indication or program specific data capture standards and AZ standards.• Provide input into CDM related activities associated with regulatory inspections/audits for assigned studies.• May provide input to the selection and use of software systems, devices and vendors.• Responsible for compliance to TMF requirements relating to DM Vendor• Drive adherence to AZ CDM standards and processes for data quality and consistency of data capturing for assigned studies• Maintain an awareness of the external and internal models in order to flag for continuous improvement related to CDM operating models.• Demonstrates willingness to take on ad hoc activities consistent with current or experience in support of CDM.• Mentoring junior CDM colleagues• Performs any CDM tasks Line Manager.