Clinical Scientific Expert I
Location: Hyderabad, India
Job ID: REQ-10060761
Business Unit: Development
Functional Area: Research & Development
Employment Type: Regular
Experience Required: 2–5 Years
Position Overview
Novartis is seeking a Clinical Scientific Expert I (CSE I) to support global clinical trials across all phases, ensuring high scientific and operational quality. This role is a key contributor within the Clinical Trial Team (CTT) and involves clinical data review, scientific insights generation, and cross-functional collaboration under the guidance of the Associate/Clinical Development Medical Director.
The CSE I ensures clinical data accuracy, identifies trends and safety signals, and supports study execution in alignment with Novartis standards, ICH-GCP guidelines, and regulatory requirements.
Key Responsibilities
Clinical Trial Execution
Contribute to all core aspects of global clinical trial activities to meet timelines, quality benchmarks, and compliance requirements.
Support issue resolution plans and operational tracking at both study and program levels.
Collaborate with cross-functional partners including Data Management, Clinical Development, Drug Supply Management, and Novartis Country Pharma Organizations.
Clinical Data Review & Insights
Perform high-quality clinical data review to ensure data plausibility, detect trends, and identify potential risks related to trial endpoints and patient safety.
Ensure all insights and reviews meet Novartis quality standards, inspection readiness, and required timelines.
Documentation & Regulatory Activities
Contribute to clinical study documents including protocols, ICFs, and clinical sections of regulatory submissions (CTA).
Monitor adherence to study plans and support final report contributions.
Safety & Compliance
Report adverse events, technical complaints, or product-related special scenarios within 24 hours of receipt.
Manage the distribution of marketing samples where applicable.
Uphold Novartis values including Integrity, Collaboration, Innovation, Quality, Courage, and Performance.
Key Performance Indicators
On-time, efficient trial execution within budget and quality expectations.
Proactive risk identification and contingency planning.
Accurate and consistent clinical data review aligned with global standards.
High-quality contributions to study documentation.
Strong collaboration and cross-functional engagement.
Minimum Requirements
Work Experience (2–5 Years Preferred)
Experience in clinical research or clinical trial operations.
Cross-cultural collaboration and ability to work across global teams.
Exposure to project management and operational execution.
Skills & Knowledge
Clinical research fundamentals
Clinical trial protocols and operations
Data integrity and clinical data review
Risk monitoring and trends analysis
Understanding of life sciences and clinical development processes
Strong analytical and problem-solving abilities
Excellent written and verbal communication in English
Why Join Novartis?
At Novartis, you become part of a global community committed to advancing science and improving patients’ lives. Our culture is built on collaboration, inclusion, and continuous learning. You will work with passionate professionals dedicated to creating meaningful breakthroughs in healthcare.
Learn more about our values and people culture:
(Official Novartis link omitted per policy but referenced as part of employer messaging.)
Benefits & Rewards
Novartis offers a comprehensive benefits program supporting personal well-being, professional development, and long-term career growth. Full benefits information is available through the company’s official handbook.
Accessibility & Accommodation
Novartis is committed to an inclusive workplace and provides reasonable accommodations for individuals with disabilities throughout the recruitment process. Candidates requiring support may contact the provided accessibility email with the job requisition number.
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