What are the responsibilities and job description for the Senior Clinical Data Manager position at Immunome, Inc.?
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
$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).
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.
- 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.
- 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.
- 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
$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).
Salary : $148,772 - $179,700