[Remote] Lead Clinical Database Programmer
Note: The job is a remote job and is open to candidates in USA. Perspective Therapeutics is seeking a Lead Clinical Database Programmer with extensive experience in programming clinical databases across multiple Electronic Data Capture (EDC) systems. This role involves leading database programming activities, collaborating with cross-functional teams, and ensuring high standards of accuracy and compliance in clinical data management.
Responsibilities
- 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
Skills
- 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
- Experience in reports/dashboard development
- Proficiency in Clinical Data Management Systems (e.g., Medidata RAVE, Oracle/Inform)
- 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)
- Good 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 priorities
- Ability to establish and maintain effective working relationships with coworkers and managers
- Must be willing to travel up to 10% of the time, as measured on a calendar quarter. Both domestic and international travel may be required
- Python or Java is a plus
- 3+ years of experience with Medidata RAVE CDMS is a plus
Company Overview
Company H1B Sponsorship