Experience

Veristat

• United States
• Research Services
• 300 - 400 Employee

• Senior Clinical Data Manager

  • Feb 2021 - Present

  • Interact with members of other functional teams (Biostatistics, Clinical Operations, Safety Surveillance, Regulatory Affairs), Vendors (Clinical & DM CROs, Labs) regarding study-related issues. • Handle data transfers from external vendors (e.g. PK, PD, ECG). • Responsible for developing the Test cases and Test plans and performed UAT for new study database. • Development and review of study documents like eCRF completion Guideline, DMP, External data reconciliation guideline, Some SOPs etc. • Strong knowledge and commitment of adherence to ICH-GCP, FDA and IRB regulations. • Responsible for developing clinical Database specifications, includes e CRF design, user requirements, edit checks, query logic and data validations. • Create Study metrics to monitor study progress to ensure the expectations are met as per the timeliness and quality. • Provide inputs for improving the operational process and workflow, while maintaining the quality outcomes. • Mentoring new joiners and providing training on organization specific Data management workflow. • Freeze and lock the data on time for preparing the database for statistical review, interim quality review and final database lock. Show less



GlobeElixir Pavt Ltd

• Clinical Data Manager

  • Mar 2014 - Dec 2019

  • Handling all the data management activities including Discrepancy Management and data reconciliations from external database. • Prepared weekly and monthly reports on the study status and present reports to the study teams. • Performed functional testing, user acceptance testing for study management reports. • Developed Edit Check Specifications for EDC and performed UAT. Also run data listings. • Worked closely with Programming team to develop and create custom reports as per the study needs. • Reviewed and understood the study protocol thoroughly to develop the study specific eCRF completion guidelines and Data Validation Specifications. • Coordinated the timely completion of the database lock procedures. • Performed variety of migration activities such as updating edit check document, modification of eCRFs, identifying and correcting misfiring checks. • Worked on study update requests for planning or performing data migration as needed. • Liaised with Sites, Site Monitors, Clinical team, Pharmacovigilance, Database programmers, Coding team and the Statistical group to coordinate various data management activities. • Performed quality control on database to ensure that the results are conforming to the quality standards. • Ensure adequate preparation for internal and external database for data management audit; respond knowledgeably and confidently to issues or questions that arise during audits. Show less