The Clinical Scientific Expert I (CSE I) provides scientific and clinical support across all phases of a clinical study, ensuring data accuracy, regulatory compliance, and quality. The role involves collaboration with cross-functional teams to monitor study progress, perform data reviews, and ensure patient safety.
Key Responsibilities
- Contribute to the design, review, and execution of global clinical trials.
- Support protocol development, ICFs, and clinical sections of CTA.
- Conduct clinical data reviews and insights aligned with Novartis standards.
- Coordinate with data management, drug supply, and clinical development teams.
- Implement issue-resolution and risk mitigation plans for assigned studies.
Qualifications & Skills
- Bachelor’s/Master’s in Life Sciences, Pharmacy, or a related field.
- 1–4 years of experience in clinical research or trial operations.
- Strong understanding of ICH-GCP and regulatory requirements.
- Skills: Clinical Research, Clinical Trial Protocols, Data Integrity, Risk Monitoring, Trend Analysis.
- Excellent communication skills and cross-cultural collaboration ability.
Relevant Experience in Clinical Research
Almost all hired candidates have experience in roles such as:
- Central Monitoring Analyst / Centralized Monitor (e.g., Pharm-Olam, IQVIA)
- Clinical Data Management or Data Review roles
- Clinical Research Coordinator / Clinical Trial Associate
- Medical Writer or Clinical Research Fellow
Location: Hyderabad (Office)
Job Type: Full-time
End Date to Apply: November 17, 2025
💡 2. Clinical Data SME – data42, Hyderabad
Job Overview
Join data42, Novartis’s cutting-edge data and AI initiative, as a Clinical Data Subject Matter Expert (SME). You’ll collaborate with engineers and scientists to transform complex trial datasets into analysis-ready assets that accelerate discovery and improve patient outcomes.
Key Responsibilities
- Partner with data engineers and scientists to interpret, transform, and validate clinical trial data.
- Guide the mapping of ADaM datasets across historical trials.
- Conduct data quality assessments and ensure compliance with CDISC standards.
- Develop documentation and share knowledge on transformation logic and data governance.
Qualifications & Skills
- 3–5 years of experience working with clinical trial data (preferably in Neuroscience, Oncology, or Immunology).
- Expertise in CDISC standards (SDTM, ADaM) and familiarity with MedDRA.
- Strong SAS, SQL, or Python skills for data transformations.
- Analytical mindset with attention to data quality and consistency.
- Experience working in global Agile teams.
- Bonus: Interest in Generative AI (GenAI).
Location: Hyderabad (Office)
Job Type: Full-time
End Date to Apply: November 30, 2025
🎯 Why Join Novartis?
- Work on cutting-edge global clinical and data science projects.
- Collaborate with world-class researchers and scientists.
- Competitive salary and comprehensive benefits.
- Opportunity to innovate with AI and data-driven healthcare initiatives.
📝 How to Apply
Eligible candidates can apply directly through the official Novartis careers portal:
🔗 Apply for Clinical Scientific Expert I
🔗 Apply for Clinical Data SME (data42)
