Note: The job is a remote job and is open to candidates in USA. Parexel is a global clinical development partner delivering clinical and consulting solutions for the life sciences industry. The Senior Clinical Database Programmer will lead the design, implementation, maintenance, and optimization of EDC systems and clinical databases, ensuring data quality, regulatory compliance, and audit readiness. The role also provides technical leadership, cross-functional collaboration, and support for clinical study operations and business development.
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
Skills
- * 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
- * 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
Benefits
- Remote work
- 6-month contractual assignment
- Continuous learning opportunities
- Career paths and opportunities to expand skills across clinical research
Company Overview
Company H1B Sponsorship