Chandra S Email & Phone Number

Canada

- Created data management plan, data transfer specification documents, data review guidelines, data entry guidelines and work instructions.- Served as lead data manager on multiple projects during same time period.- Responsible for the planning, implementation and overall direction of executing/achieving clinical trial data management activities including Electronic- Case Report Forms (eCRF) design, database development, validation programming, discrepancy management and database release- Responsible for generating and resolving Data Clarification Requests, tracking all through resolution while working collaboratively with Clinical Coordinators and Clinical Research Associates.- 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.- Led data collection and data clean-up activities including ongoing site management for issue resolution.- Utilized SAS to ensure data readiness for analyses and locks.- Built eCRFs and implemented edit checks in the Adaptive clinical database system.- Rectified project tracking system for data management activities.

Ontario, Canada

- 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 CRF completion 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, ECGs, images), SAE reconciliation, and medical data listing review- Created a CRF cleaning checklist for the data managers; assisted in the development of review guidelines and edit checks.