Senior EDC Programmer

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.