Devendra Naidu Email & Phone Number

Canada

Responsible for all Data Management (DM) activities including the application of data standards, data management plan, risk indicator, and third-party data.Served as lead data manager on multiple projects during same time period.Responsible for the planning, implementation and overall directionof executing/achieving clinical trial data management activities including Electronic Case Report Forms (eCRF)design, database development, validation programming, discrepancy management anddatabase releaseResponsible for generating and resolving Data Clarification requests, tracking all through resolution while working collaboratively with Clinical Coordinators and Clinical ResearchAssociates.Liaised with monitor, database programming, medical coding and statistical programming teams to ensure smooth functioning of studies.Trained and assigned tasks to junior data management personnel.Develops and or ensures quality in the database design including both CRF and non-CRF data collection modules, edit checks and data review listing, and other activities up todatabase releaseReviewed and tested eCRF screen design and written data management plans for EDCDeveloped DA, CRF completion guidelines and other DM specific documentsResponsible for listings review and performed QC of the data.Proactively drives quality of deliverables as well as ensures timelines and milestones are met in collaboration with cross functional teams.Ensures final database DM documents are complete and all data issues have been tracked, reviewed, reconciled, and resolved per SOPs.

India

Performed Clinical Data Review and Query Maintenance.Data processing including updating, cleaning, quality checks on the database, and Serious Adverse Event reconciliation to highlight discrepancies.Ensured clean data resolution was in order for database locks.Designated tasks appropriately within the team ensuring all work conducted were completed to the acceptable quality in accordance with global Standard Operating Procedures (SOPs) and the DVM, DVGs.Reviewed protocols for proper data capture including Case Report Form (CRF) design and CRFcompletion guidelines.Performed all clinical data activities on assigned projects including pre-entry data review, data validation and query integration and resolution. Utilized study documentation including protocols and case report forms to perform review and validation.Performed vendor data reconciliation (labs, ECG, images), SAE reconciliation, and medical data listing reviewReviewed Query track report, SAE track report and raised questions during cross functional meeting for unaddressed queries.Worked with database developers in designing the database, testing and implementation of the study databases.Developed case report form and CF completion guidelines.Reviewed and tested the EDC functionality and validation procedures.Involved in designing a data management plan for EDC and data transfer agreement for transferring data from external vendors for vaccine related trials.Responsible for project management activities which include tracking clinical study progress and assessing timelines and study requirements.