Role & responsibilities

- Work as a Clinical Data Management (CDM) Programmer supporting clinical studies.
- Perform technical and programming tasks for assigned projects, ensuring high data quality and compliance.
- Design and implement complex edit checks, data validations, and derivations.
- Set up, manage, and validate electronic data imports and exports.
- Prepare datasets and documentation for study completion and regulatory submissions.
- Conduct quality control (QC) checks on programming outputs.
- Support reporting programming and ensure timely delivery against project schedules.
- Monitor systems for workflow alerts, performance issues, and resolve programming defects.
- Contribute to process improvements, standardisation, and best practices.
- Manage User Access Management (UAM) for EDC studies and maintain related documentation.
- Collaborate with cross-functional teams and support system integrations, updates, and UAT activities.
- Ensure compliance with study standards, SOPs, and regulatory requirements.

Preferred candidate profile

Knowledge

- Bachelor's degree required; Master's degree preferred.




- Equivalent combination of education and relevant experience will be considered.
- Understanding of clinical data management processes and standards.

Work Experience

- Minimum 3+ years of experience in Clinical Data Management.
- Experience supporting clinical trials and working with EDC systems.

Skills

- Proficiency in EDC platforms such as Medidata Rave, Veeva, Medrio, Viedoc, etc.
- Strong knowledge of SAS and clinical programming concepts.
- Experience with programming languages such as PL/SQL, SAS, C#, or VB (preferred).
- Familiarity with edit checks, derivations, database setup, and data validation processes.
- Experience with application programming and system integrations.
- Solid understanding of quality standards and SOP-driven environments.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Excellent written and verbal communication skills.
- Ability to collaborate with internal teams and external stakeholders effectively.
- Experience in a matrix organisational structure is an advantage.

📌 Clinical Database Programmer (Karnataka)
🏢 Quanticate
📍 Karnataka