• Creation of Data Management study documentation that includes CRFs completion guidelines, database specifications, edit checks, data review plans, data transfer specifications, SAE reconciliation plans, and external vendor data reconciliation plans.• Reviews clinical data and metrics to identify data quality trends, compliance with the protocol, consistency of data across subjects and sites and potential risks to timelines.• Produces regular data listings for the clinical team.• Generate and close/resolve (as appropriate) data queries.• Perform User Acceptance Testing and collaboratively work with CDMS personnel on the issues for re-testing and resolution.• Freeze and/or lock eCRFs (as appropriate) within the Electronic Data Capture System.• Prepare Status reports and summaries of collected data for analysis.

• Development of CRFs and CRF Completion Guidelines • Collect and document data in accordance with protocol-specific procedures.• Perform quality control checks on data to identify and resolve discrepancies.• Maintain accurate and complete study records including filing, archiving and inventory of study documents.• Identify data trends and report inconsistencies to applicable data management personnel; collaborate to develop and implement actions to address.• Perform data entry or quality control review of local lab data.

• Directing strategy towards the profitable growth and operation of the company.• Instrumental in identifying new clients in local Market and developing new Business opportunities.• Evaluation of Resource utilization and profitability from the projects. Initiating measures for continuous improvement of Utilization and profitability.

• Review and understand the study protocol, regulatory requirements, study requirements with timelines and planning activities in accordance. • Reconcile project files, reports, listings, and other documents generated for accuracy and completeness of data management processes.• Complete reconciliation of external data such as Central lab.• Handled SAE reconciliations and created SAE Listing and feedback for on the SAE Tracker among departments.• Generate, track, and resolve data clarification forms (DCFs) and queries.• Interacting with clients and clinical sites to overcome any issues or data handling challenges.• Prepare study reports and metrics periodically for sponsor review.