Tasks

  • Design, build, maintain, and close clinical study databases utilizing EDC and paper-based systems
  • Develop and maintain CDISC-compliant data standards, data mappings, and related documentation
  • Develop programs for data extractions, listings, edit checks, protocol deviation reports, and custom functions
  • Implement and manage CRF and non-CRF data processing procedures
  • Test clinical databases and validation procedures to ensure high data integrity and quality
  • Monitor and coordinate data management activities across multiple clinical trials
  • Identify process improvement opportunities and support the implementation of new technologies
  • Support programming deliverables for regulatory submissions and audit requirements
  • Provide technical guidance and mentoring to team members

Qualifications

  • Associate degree, Bachelor's degree, or equivalent in Mathematics, Informatics, Engineering, or a related field
  • Minimum of 5 years of programming experience in Clinical Data Management within a pharmaceutical company or CRO
  • Solid understanding of CDISC and SDTM data standards
  • Practical hands-on experience with Clinical Data Management Systems, EDC platforms, and reporting tools
  • Sound knowledge of ICH-GCP, 21 CFR Part 11, and international clinical research regulations
  • Advanced English communication and language skills
  • Clinical trial database design and validation
  • Database build, data derivations, coding, and discrepancy management
  • Clinical data reporting and data extraction programming
  • Development of global data standards and data mappings
  • Proficiency in Microsoft Office and Windows environments