Clinical Data Manager
CurrentDevelop and maintain data management documentation, including study protocols, case report forms and data management plans.Design case report forms (CRFs) and electronic data capture (EDC) systems for data collection.Perform data entry and cleaning activities, including discrepancy management and query resolution.Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.Develop and execute standard operating procedures (SOPs) for approval, data entry screen design and testing, validation check testing and approval.Collaborate with study team members to resolve data-related issues and discrepancies.Generate and review data listings, summaries and reports for clinical study reports.Serve as a primary or backup resource for issues about data management.Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations.Contribute to the development and validation of data management software tools.
