Lead Clinical Database Programmer

Perspective Therapeutics is seeking a Lead Clinical Database Programmer with extensive experience in programming clinical databases across multiple EDC systems. The role involves leading database build, maintenance, and closeout activities, collaborating with cross-functional teams, and providing technical leadership and mentorship.

Location: Remote

Responsibilities

• Develop, deploy, and maintain study databases for clinical trials.
• Configure study-specific builds within EDC systems and support integrations with external systems.
• Design and create clinical databases optimized for data validation, review, and analysis.
• Assist in developing and maintaining clinical programming documentation.
• Program, test, and validate electronic edit checks, data listings, and reports.
• Utilize programming languages (e.g., C#, SQL, SAS) to develop and test data outputs and reporting tools.
• Perform and document all database programming activities across the study lifecycle.
• Support post-production changes, enhancements, and issue resolution.
• Contribute to study timelines for database build, validation, and deployment.
• Apply and promote CDISC standards in database design.
• Develop and maintain programming documentation, including specifications and validation records.
• Support regulatory inspections and audits.
• Contribute to SOPs, standards, templates, and best practices.
• Partner with clinical teams to translate protocol requirements into database specifications.
• Provide technical expertise on EDC capabilities and system integrations.
• Build and maintain relationships with internal teams and external vendors.
• Serve as technical lead and subject matter expert.
• Mentor team members and drive process improvements.

Requirements

• Master’s or bachelor’s degree in computer science, information technology, life sciences, or related field.
• Minimum 5 years of experience in Clinical Database Programming.
• Knowledge of database build process and drug development processes.
• Proficiency in C#, SQL, SAS, and experience with Python or Java is a plus.
• Experience in reports/dashboard development.
• Proficiency in Clinical Data Management Systems (e.g., Medidata RAVE, Oracle/Inform).
• Strong understanding of clinical trial process, regulatory requirements (e.g., ICH-GCP), and documentation.
• Familiarity with clinical data standards (CDISC, CDASH) and coding standards (MedDRA, WHODrug).
• Experience with clinical technologies and regulatory submissions.
• Understanding of medical coding database structures.