Senior Clinical Data Manager

Position Overview

The Senior Clinical Data Manager (Sr. 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. The ideal candidate is a proactive problem solver with experience in data standards, EDC systems, and cross-functional collaboration.

Responsibilities

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.

Qualifications

• Bachelor’s degree in relevant field
• A minimum of 5 years of Clinical Data Management experience in the biotech/pharma industry. Oncology experience is strongly preferred.

Knowledge and Skills

• 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