Ing. KOTESWARA NAIK

• Solves moderate to high complexity problems based on advanced to sophisticated analytical skills and complex judgement. • Works effectively in a mixed environment and uses best practices and knowledge or even interpretation of internal and external business issues to improve products or services and to define processes and standards.

• Serve as primary point of contact for customer on data management deliverables • With guidance, create and/or review and sign-off on all data management plan (DMP) documents. • With minimal guidance, provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise.

• Protocol Reviews • Database Design • User Acceptance Testing • Edit Check Preparation • Edit Check programming • Test Date Preparation • Test Date Entry • Database Inside and Outside Medrio Testing • Medidata Rave Data Base Designing, Edit Check Specification Preparation and testing. • CDSIC- SDTM (eCRF Annotation).

• Performed the data entry into database. • Designing the CRF as per the protocol and CRF completion guidelines and annotating CRF detailing the database attributes • Review, analyze, and validate clinical trial data in CRF for consistency, integrity and accuracy based on project specific guidelines • Perform User acceptance test (UAT) for Database validation