Senior Clinical Database Programmer

Key Responsibilities

• Lead and supervise the design, implementation, and maintenance of electronic data capture (EDC) and clinical database management systems (CDMS) in standard or CDISC-compliant formats, ensuring regulatory compliance and first-time quality on all deliverables
• Create, implement, and maintain consistency checks and edit checks in standard or CDISC format, following internal SOPs and external regulatory requirements including 21 CFR Part 11 and ICH-GCP guidelines
• Provide technical leadership and mentorship to programming teams and project staff, including training on eCRF design, database procedures, and best practices in clinical data management
• Serve as the primary technical contact and liaison with sponsors, data management leaders, and cross-functional teams regarding database programming issues, technical solutions, and project timelines
• Manage database lock/unlock procedures and approve database changes in accordance with SOPs, ensuring adherence to service level agreements and regulatory requirements
• Maintain comprehensive technical and regulatory documentation for clinical databases, including deviation logs and traceability records to ensure compliance and audit readiness
• Support the integration and programming of systems within the Global Data Operations area, including CTMS, safety systems, and coding systems, while executing multiple programming languages and processes
• Develop, improve, and implement project-specific tools and standards that enhance efficiency and optimize clinical trial processes across multiple concurrent projects
• Participate in business development activities, including bid defense meetings and technical support for new business opportunities

You'll thrive in this role if you bring

Required Qualifications

• 6 to 7 years of experience in clinical data programming
• Proficiency in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java)
• Strong knowledge of SOPs, guidelines, work instructions, SDLC methodologies, ICH-GCP, and applicable regulatory requirements including 21 CFR Part 11
• Demonstrated experience in the clinical research industry or similar regulated environment
• Strong communication, organization, and problem-solving skills with proven ability to work independently and collaboratively

Preferred Qualifications

• Bachelor's degree in relevant science discipline or equivalent work experience
• Certification in at least one clinical systems platform (e.g., Inform, RAVE, DataLabs, Medrio, Veeva)
• Experience with multiple systems used in clinical trial processes (e.g., CTMS, medical safety reporting systems, or additional EDC platforms)
• Presentation skills and experience supporting business development activities
• We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.
• If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be perfect fit, send them the link to apply!