Senior Clinical Data Manager

Benefits

Qualifications

• •The ideal candidate is a proactive problem solver with experience in data standards, EDC systems, and cross-functional collaboration
• •Bachelor’s degree in relevant field
• •A minimum of 5 years of Clinical Data Management experience in the biotech/pharma industry
• •Demonstrated expertise with EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva CDMS)
• •Understanding of clinical trial methodology, regulations, and data standards
• •Experience leading data management activities for Phase I–III global clinical trials
• •Vendor oversight experience and ability to drive cross-functional alignment
• •Knowledge of FDA, ICH-GCP, and 21 CFR Part 11 compliance
• •Excellent communication, documentation, and project management skills
• •6 more items(s)

Responsibilities

• •CDM) is responsible for leading end-to-end data management activities across one or more complex clinical trials
• •This role ensures high-quality, reliable clinical data that meets regulatory standards and supports timely clinical development decisions
• •Study Planning & Start-Up
• •Serve as the data management lead for assigned clinical studies, providing strategic input into protocol design and data collection strategy
• •Develop and manage Data Management Plans (DMPs), CRF/ eCRF specifications, edit check specifications, and data validation plans
• •Lead EDC system set-up, UAT, and deployment; coordinate with external vendors and internal biometrics teams
• •Execution & Oversight
• •Oversee all data review activities, including query management, data cleaning, discrepancy resolution, and ongoing data quality monitoring
• •Ensure adherence to CDISC/CDASH/SDTM standards where appropriate, as well as applicable regulatory requirements (ICH-GCP, FDA, EMA)
• •Track study metrics, identifying risks and implementing mitigation strategies to maintain high-quality and timely deliverables
• •Manage interactions with CROs, central labs, imaging vendors, and other data contributors
• •Close-Out & Reporting
• •Lead database lock activities, ensuring audit readiness and complete documentation
• •Support statistical programming and medical writing teams in delivering data for interim analyses, CSR outputs, and regulatory filings
• •Contribute to process improvements and knowledge sharing within the data management function
• •12 more items(s)