[Hiring] Clinical Database Programmer @Parexel

Role Description

Join our team as a Clinical Database Programmer on a 6-month contractual assignment. We are particularly interested in candidates who are available to join immediately. In this role, you will be responsible for supporting clinical database programming and ensuring high-quality data delivery for clinical studies.

As a Clinical Database Programmer, you will provide technical expertise and strategic leadership in the design, implementation, and management of electronic data capture (EDC) systems and clinical databases that directly impact the integrity and success of clinical trials. This position plays a key role in ensuring regulatory compliance, data accuracy, and system optimization while advancing patient safety and research quality. You'll collaborate with cross-functional teams including sponsors, data management leaders, and clinical operations, follow industry-standard processes and regulatory requirements, and contribute to study operations from planning through closeout.

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.

Qualifications

• Technical expertise in clinical database programming, EDC systems, and CDMS platforms with a proven track record of delivering high-quality, compliant solutions.
• Strong leadership and mentoring capabilities with the ability to guide and motivate virtual teams across multiple time zones and cultures.
• Excellent communication skills with the ability to translate complex technical concepts for diverse audiences including sponsors, regulatory bodies, and internal stakeholders.
• Deep understanding of regulatory requirements, ICH-GCP, 21 CFR Part 11, and SDLC methodologies with demonstrated commitment to quality and compliance.
• Problem-solving mindset with the ability to make sound decisions in ambiguous situations and conduct root cause analyses.
• Flexibility and adaptability with a commitment to continuous learning in an evolving technical environment.

Requirements

• 2 to 9 years of experience in clinical data programming.
• Proficiency in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java).
• Experience with Custom Function programming will be added advantage.
• 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., 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

• Flexibility, growth, and creating space for people to do their best work.