Principal Clinical Database Programmer

4 weeks ago

Delhi, Delhi, India Veramed Full time

Job Title : Principal Database and Validation, Analytical Programmer

Experience : 7+ Years

Department : Clinical Data Management / Programming

Employment Type Full-time

Purpose :


As a Principal Database and Validation, Analytical Programmer, you will be responsible for the end-to-end programming and configuration of Electronic Data Capture (EDC) systems and associated clinical data modules such as ePRO and RTSM. You will also lead the generation of validation outputs, analytical visualizations, and database solutions that support clinical trial data integrity, risk-based monitoring, and regulatory compliance.

Key Responsibilities :

EDC & Module Programming :

- Design and program EDC databases based on study protocols with high accuracy and efficiency.

- 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 :


- Develop validation listings and outputs outside of the EDC to support data cleaning and monitoring.

- 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.

(ref:hirist.tech)

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