Company Overview
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC.
We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.
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 asapplicable 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 of5years 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.
Washington State Pay Range$119,824 - $152,725USD
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
E-Verify
Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).
