Clinical Data Manager
Current• Ensured thorough execution of User Acceptance Testing (UAT) and comprehensively documented the process. Promptly identified and addressed any issues, facilitating their resolution. Actively oversaw discrepancy management to maintain data quality in alignment with the Data Quality Plan, consistently conducting checks during study implementation.• Conducted data analysis to foster a profound comprehension of the study's intricacies, thereby accurately evaluating both study progress and data reliability.• Orchestrated, coordinated, and supervised assessments involving surgery, chemotherapy, pathology, radiology, and radiation therapy. Compiled data from these evaluations as specified by the protocol.• Aided the Database Administrator in crafting the clinical study database in accordance with relevant protocols and procedures.• Generated mock data for the purpose of testing data entry interfaces and edit checks.• Validated data entry screens and edit check programs for accuracy and coherence.• Diligently reviewed and processed clinical trial data, ensuring the precision and uniformity of the clinical trial database.• Managed data tracking and internal reviews through the development or application of Case Report Form (CRF) tracking documents. Conducted in-house CRF reviews to verify compliance with protocol requirements and project-specific criteria.• Documented and rectified any identified errors, omissions, or discrepancies encountered during data analysis. Collaborated closely with both internal and external project teams to effectively address and resolve issues as necessary.• Overlooked study activities, encompassing patient enrollment and randomization, to ensure smooth study execution.• Validated data fields in the database against CRF when applicable/ validated the clinical trial database's using ad hoc queries