Principal Clinical Database Programmer

Job Title : Principal Database and Validation, Analytical Programmer

Experience : 7+ Years

Department : Clinical Data Management / Programming

Employment Type Full-time

Purpose :

- Configure additional systems including ePRO, eSource, RTSM, and other trial-specific modules.

- Develop and implement both standard and complex edit checks, including custom functions.

Database Lifecycle Management :

- Lead study database design, setup, testing (UAT), deployment, and maintenance throughout the clinical trial lifecycle.

- Collaborate closely with data management and study teams to refine database specifications and configurations.

- Conduct quality control and validation prior to key releases (UAT, Production).

Data Validation & Reporting :

- Create risk-based monitoring reports, including Key Risk Indicators (KRIs) and critical-to-quality metrics.

- Generate protocol deviation reports based on EDC data and trend them over time.

- Build ad-hoc data reports to support internal teams for ongoing data review and decision-making.

Data Analytics & Visualization

- Deliver graphical and visual analytical outputs using programming languages/tools (e.g., R, Python, SAS, or similar).

- Develop data status and trending reports including missing data, SDV status, queries, and review tracking.

Compliance & Validation

- Lead Computer Software Validation (CSV) efforts and ensure ongoing compliance with regulatory standards.

- Manage software upgrades and technology transitions, assessing their impact on clinical operations.

Process Improvement & Leadership

- Contribute to the development of SOPs, templates, and best practices for database programming and validation.

- Mentor junior programmers and provide technical guidance across clinical data programming teams.

- Participate in internal training, project timelines, milestone tracking, and documentation updates.

Minimum Qualifications :

- Bachelors degree in Computer Science, Life Sciences, or a related field.

- Minimum 7 years of experience in database programming for clinical trials.

- Certified in Medidata Rave (or equivalent EDC system).

Key Skills & Competencies :

- Strong understanding of clinical trial data architecture and workflows.

- Proficiency in EDC systems, with experience configuring ePRO, RTSM, and edit checks.

- Analytical mindset with experience in creating data visualizations, deviation tracking, and monitoring reports.

- Familiarity with clinical data standards (e.g., CDISC, SDTM).

- Excellent attention to detail and ability to meet tight deadlines.

- Strong verbal and written communication skills.

- Ability to work independently as well as within cross-functional project teams.

Preferred Tools/Technologies :

- EDC Systems: Medidata Rave (required), Oracle InForm, Veeva Vault CDMS (nice to have).

- Programming: SQL, SAS, R, Python, or other statistical/visualization tools.

- Reporting: Spotfire, Tableau, Power BI (optional but beneficial).

- Familiarity with SDLC, GCP, 21 CFR Part 11 compliance, and validation documentation.