Sr. Clinical Data Manger

Responsibilities :

• Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close.
• This includes the EDC build and user acceptance testing (UAT), study data cleaning and reconciliation, query issue and resolution, and database locks.
• They will ensure optimized data collection, flow and access across EDC and non-EDC data sources.
• They are also responsible for accuracy, consistency, completeness and CDISC compliance of all clinical databases.
• The role will operate as a key member of the Clinical Operations team.
• Develop and maintain all data management documentation, including case report forms, data management plans, edit check specifications, data review plans and data transfer agreements.
• Design case report forms (CRFs) for 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.
• Collaborate with study team members to resolve data-related issues and discrepancies.
• Generate and review data listings, summaries and reports for data review.
• 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.

Requirements :