About the role
Responsibilities
- Lead clinical data management activities for multiple complex studies, from study startup to database lock and final reporting.
- Develop and manage data management timelines for multiple projects, ensuring all milestones are met according to project plans.
- Design, build, and oversee the implementation and management of clinical trial databases using Electronic Data Capture (EDC) systems (e.g., Medidata, Medrio, or similar).
- Develop and oversee maintenance all data management documentation for all clinical studies.
- Ensure clinical data is captured accurately and efficiently, incorporating appropriate data validation checks and edit checks.
- Oversee data validation processes, including data cleaning, discrepancy management, and query resolution.
- Ensure data accuracy, completeness, and compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (CDISC, SDTM, WHO Drug, MedDRA).
- Perform data review and provide feedback to study teams to improve data quality and resolve issues early in the trial process.
- Ensure clinical data management activities are compliant with regulatory requirements (FDA, EMA), ICH GCP guidelines, and other relevant regulations.