Clinical Database Programmer
Posted Updated
We are seeking a highly skilled Clinical Database Programmer with hands-on expertise in Veeva EDC (Vault CDMS) and Veeva Builder. In this role, you will be responsible for designing, configuring, and maintaining clinical databases that ensure data integrity, accuracy, and compliance throughout all phases of clinical trials. You will collaborate closely with cross-functional teams to deliver reliable, high-quality data that supports critical decisions in clinical research and advances healthcare innovation.
Key Responsibilities:
- Design, build, and validate clinical trial databases using Veeva EDC (Vault CDMS), including CRF design, edit checks, and custom form configurations.
- Implement and execute data validation procedures and quality control measures to ensure data accuracy, consistency, and completeness.
- Collaborate with cross-functional teams (biostatistics, clinical operations, programming, and project management) to ensure seamless data flow and consistency across systems.
- Generate, review, and deliver data listings, reports, and outputs in support of clinical trial deliverables.
- Act as the primary technical contact for database-related activities and ensure the timely resolution of database or data quality issues.
- Ensure all database development activities adhere to GCP, ICH, CDISC, and regulatory standards (FDA/EMA).
- Identify opportunities to improve database build processes, automation, and efficiency.
Qualifications:
- Bachelor’s degree in Life Sciences, Computer Science, Statistics, or a related field; Master’s degree preferred.
- Minimum 3 years of experience in clinical data management or programming within a CRO, pharmaceutical, or biotech setting.
- Proven expertise with Veeva EDC (Vault CDMS), including Veeva Builder experience (certification highly desirable).
- Strong understanding of clinical data management principles, regulatory standards, and data lifecycle management.
- Experience with CDISC/CDASH/SDTM standards.
- Proficiency in SQL and data reporting tools.
- Advanced knowledge of Microsoft Office Suite and familiarity with SAS, Python, or JavaScript is a plus.
- Excellent problem-solving, communication, and organizational skills, with the ability to manage multiple projects in a fast-paced environment.
- Proficiency in written and spoken English (upper-intermediate or higher).