• Worked with CRO DM to determine and implement database lock timelines• Ensured the lock activities are performed and completed by CRO DM as outlined in DMP. Such lockactivities include ensuring the writing and sending of all queries have been carried out. By this stage, the DBmust have been up to date and all third party/ External data must have been received and reconciled.• Ensured Database Specification Document (DSD), eCRF, Edit Check Specification (ECS), eCRFCompletion Guidelines eCCG, UAT plan, UAT test cases and DMP documents are drafted by CRO team and reviewed by our internal team before finalization and approver. • Represented data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors• Reviewed and understood the study protocol thoroughly to develop the Data Management Plan, study specific eCRFs and Data Validation Specifications• Involved in validating the database by creating raw data and conducted UAT testing.• Generated and reviewed data listings and queried for inconsistent data (I-Review, CDR)• Participated in study management team meetings and provided and managed minutes.• Built effective relationships with Coding, Clinical, Safety, and Bio-statistical groups to work towards acommon goal of creating a clean and robust database.• Developed Data entry guidelines, Data management conventions for the DMP, electronic CRF completionguidelines, and data review guidelines.• Performed SAE reconciliation on a monthly basis.• Performed various quality control activities.• Maintained knowledge of SOPs, WIs, 21 CFR Part 11guidelines• Performed data review and query management.• Performed QC and testing of eCRFs, edit checks, and data listings during start up.• Designed CRFs and wrote User Acceptance Test scripts.• Executed User Acceptance Tests for eCRFs, edit checks, electronic data handling, and data listings.

System Implementation• Partner closely with Client Service Lead in support of implementation of client RTSM applicationsto enable client start up targets.• Attend client meetings and design sessions. Al through the study• Log, track, and drive resolution of functional and technical issues discovered during implementation and prior to go live.• Ensures adherence to required deliverables and milestones of project management SOP.• Drive project specific validation activities including study testing, system setup and implementation activities.• Support system integration activities (EDC, Supply, DTAs)• Perform build verification testing using test scenarios and acceptance criteria.• Support UAT with clientsSystem Operations• Develop, implement, and oversee client communication plans, including service level agreements data management and support procedures, as per 4G clinical SOPs.• Support client services lead in supplies consulting and analysis required.• Customer support point of escalation for any system or support issues where required.• Develop, training materials and train customer support staff on study application support procedures and client standards.• Monitor study issues for trends to enhancement opportunities or additional training needs.• Develop client governance materials and participate in client business reviews.• Participate in client audits.