Clinical Database Programmer
About Quadrangle:
Quadrangle is seeking a highly motivated and experienced Clinical Database Programmer to join our growing team in Gurugram. In this role, you will be responsible for the design, development, validation, and maintenance of clinical databases used in clinical trials. The ideal candidate will possess a strong understanding of clinical data management principles, EDC systems, and CDASH standards. If you are looking for a challenging and rewarding opportunity to contribute to the advancement of healthcare, we encourage you to apply.
Job Summary:
The Clinical Database Programmer will play a critical role in supporting clinical trials by ensuring the integrity, accuracy, and compliance of clinical data. This individual will be responsible for designing and developing electronic Case Report Forms (eCRFs), implementing edit checks, performing database testing, and collaborating with cross-functional teams.
Responsibilities:
- Review functional requirement documents from clinical project teams.
- Develop, validate, and maintain eCRFs and related EDC modules.
- Create standard CDASH-compliant CRF libraries.
- Implement edit check specifications and quality control checks per study protocol.
- Perform mid-study database updates based on approved change requests.
- Provide annotated and blank CRFs to stakeholders.
- Update Standard Operating Procedures (SOPs) in alignment with regulatory changes.
- Manage user/site administration, including roles, access, and permissions.
- Ensure secure database access and compliance.
- Perform database testing and maintain audit-ready documentation.
- Collaborate with the EDC product support team for troubleshooting and enhancements.
Requirements:
- Education: B.Pharm, M.Pharm, B.Tech/M.Tech (Biotechnology/Bioinformatics/Biomedical Engineering/Computer Science) or equivalent.
- Experience: Minimum 3 years of experience in clinical data management with 1–2 years of experience in database design.
- Strong knowledge of EDC systems (Zelta platform highly preferred, Veeva EDC desirable).
- Familiarity with CDASH and SDTM standards.
- Experience with Power BI or other data visualization tools is a plus.
- Preferred experience in Oncology, Hematology, Neurology, Cardiology, or medical device studies.
- Strong understanding of database structure, edit checks, and clinical protocol requirements.
Preferred Skills:
- Zelta (formerly IBM/Merative Clinical Development) certification.
- Knowledge of Endpoint Adjudication, Data Migrator, Smart Report, and Inventory modules within EDC systems.
Benefits & Growth Opportunities:
- Competitive compensation package (₹13–15 LPA based on experience).
- Exposure to global clinical trials and regulatory workflows.
- Opportunity to work with leading experts in clinical data management.
- Skill development in advanced EDC platforms and medical device studies.
Job Location:
Gurugram, Haryana, India (Full-time, permanent role)
How to Apply:
If you are a qualified and enthusiastic individual looking for a challenging and rewarding opportunity, we encourage you to apply. Please submit your resume and cover letter detailing your relevant experience and qualifications through the application link provided below.
[Application Link]
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.