Parexel is hiring a Clinical Database Programmer for a 6-month contractual assignment. The role focuses on clinical database programming, electronic data capture (EDC) systems, clinical database management systems (CDMS), consistency checks, regulatory compliance, and high-quality data delivery for clinical studies. Candidates who are available to join immediately are particularly sought.

Job Details

Position

Clinical Database Programmer

The Clinical Database Programmer will support the design, implementation, and management of EDC systems and clinical databases, ensuring data accuracy, regulatory compliance, and system optimization throughout clinical studies.

Responsibilities

• Lead the design, implementation, and maintenance of EDC and CDMS platforms in standard or CDISC-compliant formats.
• Create, implement, and maintain consistency checks and edit checks.
• Ensure compliance with SOPs, 21 CFR Part 11, ICH-GCP, and applicable regulatory requirements.
• Provide technical leadership and mentorship to programming teams and project staff.
• Train teams on eCRF design, database procedures, and clinical data management best practices.
• Act as the primary technical contact for sponsors, data management leaders, and cross-functional teams.
• Manage database lock/unlock procedures and approve database changes according to SOPs.
• Maintain technical and regulatory documentation, including deviation logs and traceability records.
• Support integration and programming of systems within Global Data Operations, including CTMS, safety systems, and coding systems.
• Develop and implement project-specific tools and standards to improve clinical trial processes.
• Participate in business development activities, including bid defense meetings and technical support for new business opportunities.

Eligibility & Qualifications

• 2 to 9 years of experience in clinical data programming.
• Proficiency in at least one programming environment such as SAS, CDMS, EDC, SQL, VB, or Java.
• Experience in the clinical research industry or a similar regulated environment.
• Strong knowledge of SOPs, guidelines, work instructions, SDLC methodologies, ICH-GCP, and applicable regulatory requirements including 21 CFR Part 11.
• Bachelor’s degree in a relevant science discipline or equivalent work experience is preferred.
• Experience with Custom Function programming is an added advantage.

Preferred Qualifications

• Certification in at least one clinical systems platform such as RAVE, DataLabs, Medrio, or Veeva.
• Experience with multiple systems used in clinical trial processes, including CTMS, medical safety reporting systems, or additional EDC platforms.
• Presentation skills.
• Experience supporting business development activities.

Required Skills

• Clinical database programming
• EDC and CDMS systems
• Clinical data management
• Programming in SAS, SQL, CDMS, EDC, VB, or Java
• EDC/CDMS implementation and maintenance
• Consistency checks and edit checks
• ICH-GCP and 21 CFR Part 11
• SDLC methodologies
• Regulatory compliance
• Technical leadership and mentoring
• Problem-solving and root cause analysis
• Communication and stakeholder management
• Organization and independent working skills

Application Details

Application Link