Immunome, Inc. · 1 day ago
Senior Clinical Data Manager
Immunome, Inc. is a clinical-stage targeted oncology company committed to developing innovative cancer therapies. The Senior Clinical Data Manager is responsible for leading data management activities across complex clinical trials, ensuring high-quality data that meets regulatory standards and supports clinical development decisions.
BiopharmaBiotechnologyMedicalPharmaceutical
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
Qualification
Required
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
Preferred
Oncology experience is strongly preferred
Company
Immunome, Inc.
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.
H1B Sponsorship
Immunome, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Public CompanyTotal Funding
$998.85MKey Investors
JPEO-CBRNDU.S. Department of DefenseRobin Hood Ventures
2025-12-16Post Ipo Equity· $400M
2025-01-29Post Ipo Equity· $150M
2024-02-13Post Ipo Equity· $230M
Recent News
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2025-12-19
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2025-12-18
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