Company Overview
Position Overview
The Senior EDC (Electronic Data Capture) Programmer (Sr. EDCP) is responsible for leading the design, development, and maintenance of clinical trial databases in an EDC system. This role will work closely with Clinical Data Management, Biostatistics, Clinical Operations, and external vendors to ensure high-quality, compliant data collection systems that support efficient trial execution.
Responsibilities
- Lead the design, build, validation, and deployment of a study build within an EDC system.
- Develop and maintain edit checks, custom functions, derivations, and integrations.
- Review study protocols and provide input on CRF design and database structure.
- Collaborate with Data Management to ensure alignment with data standards (CDISC, SDTM where applicable).
- Perform User Acceptance Testing (UAT) and support database releases and migrations.
- Ensure EDC systems comply with regulatory requirements (FDA, ICH-GCP, 21 CFR Part 11).
- Troubleshoot and resolve database issues in a timely manner.
- Oversee and/or mentor junior programmers or external vendors.
- Contribute to SOP development and process improvements.
- Support data integrations with external systems (IRT, ePRO, labs, etc.).
- Maintain documentation including specifications, validation records, and audit trails.
Qualifications
- Bachelor’s degree in relevant field.
- A minimum of 5 years of EDC programming experience in the biotech/pharma industry. Oncology experience is preferred.
Knowledge and Skills
- Strong hands-on experience with at least one major EDC platform (Medidata Rave preferred).
- Solid understanding of clinical trial processes and data flow.
- Experience with CDISC standards (SDTM, CDASH) is preferred.
- Familiarity with regulatory requirements (ICH-GCP, 21 CFR Part 11).
- Strong problem-solving skills and attention to detail.
- Ability to manage multiple studies and priorities.
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).
Skills Required
- Bachelor's degree in relevant field
- Minimum of 5 years of EDC programming experience in the biotech/pharma industry
- Strong hands-on experience with at least one major EDC platform
- Experience with CDISC standards
- Oncology experience is preferred
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.
