Senior Clinical Database Programmer
Parexel International Corporation2 hours ago
Tokyo, JapanSenior
Responsibilities
- Lead and supervise 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 in accordance with SOPs and regulatory requirements.
- Provide technical leadership, mentoring, and training to programming teams and project staff.
- Act as the primary technical contact for sponsors, data management leaders, and cross-functional teams.
- Manage database lock and unlock procedures and approve database changes according to SOPs and service-level agreements.
- Maintain technical and regulatory documentation, deviation logs, and traceability records for audit readiness.
- Support integration and programming of CTMS, safety, and coding systems within Global Data Operations.
- Develop and implement tools and standards that improve efficiency across concurrent clinical trial projects.
- Participate in bid defense meetings and provide technical support for new business opportunities.
Requirements
- 6 to 7 years of experience in clinical data programming.
- Proficiency in at least one programming environment, such as SAS, CDMS, EDC, SQL, VB, or Java.
- Strong knowledge of SOPs, guidelines, work instructions, SDLC methodologies, ICH-GCP, and applicable regulatory requirements including 21 CFR Part 11.
- Experience in the clinical research industry or a similar regulated environment.
- Strong communication, organization, problem-solving, and independent working skills.
- Bachelor's degree in a relevant science discipline or equivalent work experience preferred.
- Certification in at least one clinical systems platform such as Inform, RAVE, DataLabs, Medrio, or Veeva preferred.
- Experience with multiple clinical trial systems, such as CTMS, medical safety reporting systems, or additional EDC platforms, preferred.
- Presentation skills and business development support experience preferred.
Benefits
- 6-month contractual assignment.
- Flexible work environment with opportunities for growth, continuous learning, and expanded skills across clinical research.