Lead Clinical Database Programmer

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop, implement, and maintain study databases to facilitate the collection, review, and analysis of clinical trial data.

• Configure study-specific builds within EDC systems and assist with integrations with external systems (e.g., IRT, Central Labs, imaging, ePRO, eCOA, CTMS, eTMF).

• Design and create clinical databases that are optimized for data validation, review, and subsequent analysis.

• Assist in the creation and maintenance of 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.

• Carry out and document all database programming activities throughout the study lifecycle, including initial database build, mid-study updates, and database closeout.

• Support post-production changes, enhancements, and problem resolution in a controlled and compliant manner.

• Contribute to the establishment of suitable study timelines for database build, validation, and deployment, ensuring alignment with overall study milestones.

• Apply and advocate for CDISC standards (e.g., CDASH, SDTM) in database design and data structure.

• Develop and maintain programming documentation, including specifications, validation documents, and change records.

• Facilitate regulatory inspections and internal audits by ensuring complete, accurate, and inspection-ready documentation.

• Contribute to the creation and ongoing improvement of SOPs, standards, templates, and best practices for database programming.

• Assist in the setup, validation, and maintenance of global libraries and standard templates.

• Collaborate with Clinical Data Management, Biostatistics, Clinical Operations, and external vendors to translate protocol and study requirements into database specifications.

• Provide technical expertise regarding EDC capabilities, system integrations, and database design decisions.

• Build and sustain strong working relationships with internal teams and external partners involved in clinical trials.

• Act as the technical lead and subject matter expert for clinical database programming.

• Offer mentorship, guidance, and support to team members.

• Promote consistency, efficiency, and continuous improvement across clinical database programming processes and tools.

⛳️ Requirements

• Master’s or bachelor’s degree in computer science/information technology, life sciences, or a related field.

• At least 5 years of experience in Clinical Database Programming.

• Familiarity with all steps and documentation involved in the clinical database build process.

• Expertise in drug development processes (trial start-up/execution) and EDC database development.

• Proficiency in C#, SQL, SAS, with knowledge of Python or Java being an advantage.

• Experience in developing reports and dashboards.

• Proficiency in Clinical Data Management Systems (e.g., Medidata RAVE, Oracle/Inform).

• Over 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 practices (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).

🏝️ Benefits

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