Novartis, a global leader in life sciences and healthcare innovation, is hiring for Clinical Research Associate, Clinical Data SME, and Study Start-Up Lead roles across India. These positions offer an opportunity to work on global drug development programs, clinical trials, and data management while ensuring compliance with ICH-GCP and regulatory standards.
If you’re passionate about advancing healthcare, managing clinical trials, and ensuring data quality, Novartis has multiple career opportunities for you in Delhi, Mumbai, and Hyderabad.
Key Responsibilities
Clinical Research Associate (CRA) – Delhi & Mumbai
- Act as the primary liaison between Novartis and clinical trial sites.
- Conduct site initiation, monitoring, and close-out visits.
- Ensure compliance with protocol, ICH/GCP, and regulatory requirements.
- Train site personnel and manage patient data integrity.
- Support audit readiness and risk mitigation strategies.
Clinical Data SME – Hyderabad
- Lead trial-level data management activities across phases I-IV.
- Develop and review protocols, amendments, and validation plans.
- Manage data load, transfers, and compliance with Novartis Clinical Data Standards (NCDS).
- Perform SAE reconciliation, third-party lab data review, and query resolution.
- Mentor junior staff and support innovation in clinical data processes.
Study Start-Up Lead – Hyderabad
- Drive global SSU planning and regulatory submissions.
- Manage SSU systems including CTMS, eTMF, and vendor tools.
- Ensure timely site activation and document readiness.
- Collaborate with regulatory, vendor management, and project teams.
- Provide proactive risk management and compliance oversight.
Qualifications Required
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related healthcare discipline.
- CRA: 0–2 years of clinical monitoring experience.
- Data SME: 3–6 years in clinical data management with cross-functional expertise.
- SSU Lead: 2–3 years in clinical operations or trial monitoring with global exposure.
- Strong knowledge of ICH-GCP, regulatory guidelines, and clinical trial processes.
- Excellent communication, problem-solving, and decision-making skills.
Benefits of Working at Novartis
- Competitive salary (₹6,00,000 – ₹15,00,000 per annum depending on role).
- Exposure to global drug development projects.
- Training and career development opportunities.
- Inclusive and diverse workplace culture.
- Contribution to life-saving therapies and innovative healthcare solutions.
How to Apply


