Data Study Manager

• The Study Manager in Data Management will be responsible for the planning coordination and execution of all data management activities for assigned clinical studies.
• This role ensures the accuracy integrity completeness and regulatory compliance of clinical trial data from study startup through database lock.
• The Study Data Manager collaborates with cross-functional teams including Clinical Operations Biostatistics Programming Medical Monitoring and external vendors to support the successful delivery of high-quality clinical data.

Duties and Responsibilities:

• Lead data management activities for assigned clinical studies in accordance with study timelines applicable regulations and company standard operating procedures (SOPs).
• Develop review and maintain study-specific Data Management Plans (DMPs) and other required documentation.
• Design review and validate electronic Case Report Forms (eCRFs) and associated database specifications.
• Coordinate the development testing and implementation of Electronic Data Capture (EDC) systems.
• Develop and review edit checks data validation rules and discrepancy management processes.
• Monitor data quality by reviewing incoming clinical data identifying discrepancies and managing data queries to investigative sites and vendors.
• Coordinate the reconciliation of external data sources including central laboratory imaging electronic patient-reported outcomes (ePRO) and other third-party data.
• Perform User Acceptance Testing (UAT) for clinical databases and system enhancements.
• Track study data management metrics and provide regular status updates to project teams.
• Collaborate with Clinical Operations Biostatistics Statistical Programming Medical Writing and external vendors to ensure data readiness for analysis.
• Lead database lock activities including data cleaning reconciliation documentation review and final quality control.
• Ensure compliance with ICH-GCP guidelines FDA regulations applicable global regulatory requirements and company SOPs.
• Support regulatory inspections and audits by providing required documentation and responses related to data management activities.
• Contribute to the continuous improvement of data management processes standards
• Support inspection readiness and regulatory submissions
• Serve as the primary DM representative on cross functional project teams and best practices.

• BS degree in science related field; equivalent education and/or relevant professional experience may be considered.