Clinical Scientific Expert I
Location: Hyderabad, India
Job ID: REQ-10060761
Category: Research & Development
Employment Type: Regular
Experience Required: 2–5 Years
Job Summary
Novartis is hiring a Clinical Scientific Expert I (CSE I) to support global clinical trials across all phases. This role contributes to the planning, execution, and oversight of clinical studies, ensuring delivery within defined timelines, quality standards, and regulatory compliance. As a core member of the Clinical Trial Team (CTT), the CSE I performs clinical data review, identifies data insights, and ensures scientific plausibility for trial endpoints and patient safety.
This position is based in Hyderabad, India, within the Development Division of Novartis Healthcare Private Limited.
Key Responsibilities
Clinical Trial Support
Contribute to all aspects of global clinical trial activities under appropriate oversight.
Support implementation of issue resolution plans and assist with program-level tracking activities.
Ensure adherence to study protocols, timelines, and compliance requirements.
Data Review & Insights
Conduct detailed clinical data review and generate insights according to Novartis quality standards.
Identify trends, safety signals, risks, and inconsistencies in study data.
Provide high-quality input to clinical study documents including protocols, ICFs, and regulatory submissions.
Cross-Functional Coordination
Collaborate with data management, clinical development, drug supply management, and country teams.
Maintain effective communication across boundaries to ensure smooth study operations.
Regulatory & Safety Compliance
Report adverse events, technical complaints, or special product-related scenarios within 24 hours.
Oversee distribution of marketing samples where applicable.
Ensure inspection readiness and documentation accuracy.
Key Performance Indicators
Timely and compliant execution of assigned clinical studies.
Accurate and consistent clinical data review aligned with Novartis quality standards.
Proactive operational planning, risk mitigation, and contingency strategies.
High-quality contributions to clinical documents and study deliverables.
Demonstration of Novartis Values: Integrity, Innovation, Quality, Collaboration, Courage, Performance.
Minimum Requirements
Work Experience (2–5 Years Preferred)
Hands-on involvement in clinical research or clinical trial operations.
Experience collaborating across global or cross-cultural teams.
Exposure to operational execution and project management.
Essential Skills
Clinical research and clinical trial protocol knowledge
Understanding of data integrity principles
Familiarity with trial risk monitoring and trends analysis
Lifesciences domain knowledge
Strong problem-solving and analytical skills
Effective communication in English
Why Join Novartis
Novartis brings together passionate, purpose-driven professionals committed to transforming patients’ lives through innovative science. Employees thrive in an environment that encourages collaboration, inclusion, continuous learning, and meaningful impact.
Learn more about Novartis’ culture and values through their official channels.
Benefits & Rewards
Novartis provides a comprehensive benefits program designed to support your professional and personal growth, including wellness support, leave benefits, and long-term career development resources.
Accessibility & Accommodation
Novartis is committed to fostering an inclusive workplace. Candidates requiring reasonable accommodation due to disability or medical condition may contact the designated Novartis support email and include the job requisition number.
Gujarat :
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tallinn |Hà Nội :
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