Senior Clinical Data Manager at Immunome, Inc.

Bothell, Washington, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Apr, 26

Salary

179700.0

Posted On

04 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Data Management, EDC Systems, Data Standards, Cross-Functional Collaboration, Query Management, Data Cleaning, Regulatory Compliance, Project Management, Oncology Experience, CDISC Standards, Data Validation, Statistical Programming, Medical Writing, Vendor Oversight, Risk Management, Data Quality Monitoring

Industry

Biotechnology Research

Description

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, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage GSI; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. 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 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 Washington State Pay Range $148,772—$179,700 USD 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).

Responsibilities

The Senior Clinical Data Manager is responsible for leading data management activities across complex clinical trials, ensuring high-quality clinical data that meets regulatory standards. This includes overseeing data review activities, managing interactions with vendors, and leading database lock activities.