Role Overview

Develop, deploy, and maintain study databases to support clinical trial data collection, review, and analysis
Configure 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 analysis
Assist in developing and maintaining clinical programming documentation
Program, test, and validate electronic edit checks, data listings, and reports to ensure data integrity and usability
Utilize programming languages (e.g., C#, SQL, SAS) to develop and test data outputs and reporting tools
Perform and document all the database programming activities across the study lifecycle, including initial database build, mid-study updates, and database closeout
Support post-production changes, enhancements, and issue resolution in a controlled and compliant manner
Contribute to the development of appropriate study timelines for database build, validation, and deployment, ensuring alignment with overall study milestones
Apply and promote CDISC standards (e.g., CDASH, SDTM) in database design and data structure
Develop and maintain programming documentation, including specification, validation documentation, and change records
Support regulatory inspections and internal audits by ensuring complete, accurate, and inspection-ready documentation
Contribute to the development and continuous improvement of SOPs, standards, templates, and best practices for database programming
Support the setup, validation, and maintenance of global libraries and standard templates
Partner with Clinical Data Management, Biostatistics, Clinical Operations, and external vendors to translate protocol and study requirements into database specifications
Provide technical expertise on EDC capabilities, system integrations, and database design decisions
Build and maintain strong working relationships with internal teams and external partners supporting clinical trials
Serve as technical lead and subject matter expert for clinical database programming
Provide mentorship, guidance, and support to team members
Drive consistency, efficiency, and continuous improvement across clinical database programming processes and tools

Requirements

Master’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).

Tech Stack

Google Cloud Platform
Java
Oracle
Python
SQL

Benefits

Must be willing to travel up to 10% of the time, as measured on a calendar quarter.

Perspective Therapeutics

Open Positions (1)

Engineering

Lead Clinical Database Programmer