FULLTIME
Principal Clinical Database Programmer (Adjudication Module)

Tech-Observer
Not specified · onsite · Posted 9d ago
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Section · 01
About this role
We are seeking a Principal Clinical Database Programmer to lead the design, development, validation, and maintenance of clinical event adjudication databases.
The successful candidate will provide technical leadership and collaborate with Clinical Data Management, Clinical Operations, adjudication teams, sponsors, and technology vendors throughout the study lifecycle.
Key Responsibilities
- Lead the development and configuration of adjudication module, including electronic forms, edit checks, review workflows, and reporting.
- Translate study protocols, endpoint definitions, and adjudication charters into database specifications and programming requirements.
- Configure workflows for event identification, case preparation, reviewer assignment, independent assessment, disagreement resolution, and final adjudication.
- Implement role-based access and blinding requirements to support independent committee review.
- Develop and maintain data transfers between clinical databases, adjudication platforms, and downstream reporting or analysis systems.
- Program data checks and reconciliation outputs to identify missing, inconsistent, or incomplete event information.
- Prepare technical specifications, test scripts, validation documentation, and change-control records.
- Lead technical testing, support user acceptance testing, and resolve database defects.
- Manage database amendments, assess their impact, and implement approved changes.
- Troubleshoot complex programming issues and provide technical guidance to study teams.
- Support database lock, final data delivery, and archival activities.
- Review programming deliverables, mentor team members, and improve reusable standards and development practices.
- Ensure work follows applicable study requirements, company procedures, and data integrity and computer system validation expectations.
Required Qualifications
- Bachelor's degree in Computer Science, Information Technology, Life Sciences, or a related discipline, or equivalent relevant experience.
- Typically 8 or more years of clinical database programming experience, including technical leadership responsibilities.
- Hands-on experience developing or configuring clinical event adjudication databases.
- Strong understanding of clinical endpoint adjudication, independent reviewer workflows, blinding, and consensus processes.
- Experience with clinical database or adjudication platforms and their programming or configuration tools.
- Proficiency in SQL and relevant scripting or programming languages.
- Experience with data integrations, reconciliation, testing, validation, and change control.
- Ability to translate clinical and operational requirements into clear technical specifications.
- Strong troubleshooting, communication, and stakeholder management skills.
- Ability to manage multiple studies and deliver high-quality work within agreed timelines.
Preferred Qualifications
- Experience supporting Clinical Endpoint Committees or Clinical Event Committees.
- Experience integrating adjudication platforms with electronic data capture systems.
- Familiarity with clinical data standards, including CDISC, where relevant to study deliverables.
- Experience with blinded clinical trials and complex endpoint review processes.
- Experience developing programming standards, reusable components, and quality review processes.
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Section · 02
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Section · Company
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Tech-Observer
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