Novartis, a global leader in healthcare and pharmaceuticals, is seeking a Clinical Scientific Expert I (CSE I) to join its dynamic team in Hyderabad. This role is pivotal in contributing to global clinical trial activities, ensuring the delivery of study outcomes within schedule, budget, and compliance standards. The CSE I will provide clinical and scientific support across all phases of clinical trials, ensuring data integrity, patient safety, and adherence to regulatory requirements.
As a core member of the Clinical Trial Team (CTT), the CSE I will collaborate with cross-functional teams, including data management, drug supply management, and clinical development, to drive trial success. This role is ideal for individuals passionate about clinical research, data analysis, and contributing to groundbreaking healthcare solutions.
Key Responsibilities
- Clinical Data Review:Â Perform clinical data review and insights to ensure scientific plausibility, identify trends, signals, and risks related to trial endpoints and patient safety.
- Study Documentation:Â Contribute to high-quality study documents, including protocols, informed consent forms (ICF), and clinical sections of Clinical Trial Applications (CTA).
- Issue Resolution:Â Implement issue resolution plans and manage interactions with relevant line functions to ensure smooth trial execution.
- Compliance:Â Ensure all activities comply with Novartis processes, ICH GCP, and regulatory requirements.
- Program Support:Â Assist with program-level activities, such as tracking program progress and risk mitigation planning.
- Reporting:Â Report technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt.
Key Performance Indicators (KPIs)
- Timely and efficient execution of assigned trials within budget and quality standards.
- Proactive operational planning with effective risk mitigation strategies.
- High-quality contributions to study documents and clinical data review.
- Demonstration of Novartis Values: Innovation, Quality, Collaboration, Performance, Courage, and Integrity.
Minimum Requirements
- Work Experience:
- Cross-cultural collaboration experience.
- Operations management and execution.
- Project management in clinical research.
- Skills:
- Clinical research and clinical trial protocols.
- Data integrity and trends analysis.
- Risk monitoring and lifecycle management.
- Languages:Â Proficiency in English.
Desired Skills
- Strong understanding of clinical trials and regulatory requirements.
- Expertise in clinical data review and insights generation.
- Ability to collaborate across boundaries and manage complex projects.
- Knowledge of lifesciences and learning design principles.
About Novartis
Novartis is a global healthcare company dedicated to improving and extending people’s lives through innovative medicines and therapies. With a presence in over 140 countries, Novartis is at the forefront of medical innovation, focusing on areas such as oncology, cardiovascular diseases, and immunology. The company fosters a culture of collaboration, integrity, and excellence, empowering employees to make a meaningful impact on global health.
How to Apply
If you are passionate about clinical research and meet the qualifications for the Clinical Scientific Expert I role, we encourage you to apply.
