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
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).
Top Skills
What We Do
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. 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 targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors.
