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Lead Clinical Database Programmer

Perspective Therapeutics

3h ago

0DevUnited Stateshimalayas
Clinical-Database-ProgrammingClinical-Data-ManagementClinical-ProgrammingEDC-ProgrammingClinical-DevelopmentClinical-Database-ProgrammerClinical-Data-ProgrammerClinical-Database-Management-LeadPrincipal-Clinical-Database-ManagerSenior-Clinical-ProgrammerLead-Clinical-Data-ManagerClinical-Data-LeadSenior

Job Description

Objective At Perspective Therapeutics, we are looking for a Lead Clinical Database Programmer with strong experience programming clinical databases across multiple Electronic Data Capture (EDC) systems. This role is responsible for leading the programming aspects of database build, maintenance, and closeout activities across clinical studies. The Lead Clinical Database Programmer will partner closely with the Clinical Data Management team and cross-functional stakeholders to ensure clinical databases are designed, implemented, and maintained with a high standard of accuracy, efficiency, and timeliness. This role also serves as a technical resource and mentor, driving consistency, quality, and innovation across database programming practices.Essential Functions Clinical Database Development & ProgrammingDevelop, deploy, and maintain study databases to support clinical trial data collection, review, and analysisConfigure study-specific builds within EDC systems and support integrations with external system (e.g., IRT, Central Labs, imaging, ePRO, eCOA, CTMS, eTMF)Design and create clinical databases optimized for data validation, review, and downstream analysisAssist in developing and maintaining clinical programming documentationProgram, test, and validate electronic edit checks, data listings, and reports to ensure data integrity and usabilityUtilize programming languages (e.g., C#, SQL, SAS) to develop and test data outputs and reporting tools Database Lifecycle ManagementPerform and document all the database programming activities across the study lifecycle, including initial database build, mid-study updates, and database closeoutSupport post-production changes, enhancements, and issue resolution in a controlled and compliant mannerContribute to the development of appropriate study timelines for database build, validation, and deployment, ensuring alignment with overall study milestones Standards, Quality & ComplianceApply and promote CDISC standards (e.g., CDASH, SDTM) in database design and data structureDevelop and maintain programming documentation, including specification, validation documentation, and change recordsSupport regulatory inspections and internal audits by ensuring complete, accurate, and inspection-ready documentationContribute to the development and continuous improvement of SOPs, standards, templates, and best practices for database programmingSupport the setup, validation, and maintenance of global libraries and standard templates Cross-Functional CollaborationPartner with Clinical Data Management, Biostatistics, Clinical Operations, and external vendors to translate protocol and study requirements into database specificationsProvide technical expertise on EDC capabilities, system integrations, and database design decisionsBuild and maintain strong working relationships with internal teams and external partners supporting clinical trials Leadership & Technical GuidanceServe as technical lead and subject matter expert for clinical database programmingProvide mentorship, guidance, and support to team membersDrive consistency, efficiency, and continuous improvement across clinical database programming processes and toolsQualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education/ExperienceMaster’s or bachelor’s degree in computer science/information technology or life sciences or related field.Minimum 5 years of experience in Clinical Database Programming.Knowledge of all the steps and documentations involved in a clinical database build process.Expertise in drug development processes (trial start-up/execution) and EDC database development.Proficiency in C-sharp, SQL, SAS, (Python or Java is a plus).Experience in reports/dashboard development.Proficiency in Clinical Data Management Systems (e.g., Medidata RAVE, Oracle/Inform). 3+ years of experience with Medidata RAVE CDMS is a plus.Proficiency in clinical database programming software and tools.Strong understanding of the clinical trial process, regulatory requirements (e.g., ICH-GCP), and good documentation process (GDP).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 (WHODrug, MedDRA).Knowledge / Skill / AbilityGood organization and planning skills.Strong problem-solving skills.Excellent written, verbal, and interpersonal communication skills, with proven ability to collaborate, communicate, and manage well at all levels of the organization.Demonstrated ability to work independently and manage projects.Ability to multi-task.Effective time management skills and ability to manage competing