Senior Clinical Data Manager

Immunome, Inc.•Bothell, WA

2d•$148,772 - $179,700

About The Position

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.

Requirements

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

Nice To Haves

Oncology experience is strongly preferred.

Responsibilities

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.
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.
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.