Clinical Data Specialist I at Novartis – Opportunity in India
Position Name: Clinical Data Specialist I (CDS I)
Organization: Novartis
Qualification:
- B.Pharm
- M.Pharm
- Pharm.D
- MSc
- BSc
- Lifesciences
Experience: 1 to 2 Years
Location: India
Job Description:
As a Clinical Data Specialist I (CDS I) at Novartis, you will support global clinical trial activities, ensuring the timely and compliant execution of studies under the guidance of the Associate Clinical Director (ACD) or Clinical Data Manager (CDM). This role involves reviewing clinical data, identifying trends, and addressing risks related to patient safety and trial endpoints. You will collaborate with cross-functional teams and contribute to clinical trial documents, ensuring adherence to Novartis standards.
Key Responsibilities:
| Area | Description |
|---|---|
| Clinical Trial Oversight | Assist in ensuring timely trial execution within schedule, budget, and quality standards. |
| Clinical Data Review | Review and validate clinical data for scientific accuracy, identifying trends or risks. |
| Cross-functional Collaboration | Work with teams such as data management, drug supply, and clinical development. |
| Issue Resolution | Support program-level tracking, planning, and issue resolution. |
| Compliance | Ensure adherence to Novartis processes, ICH GCP, and regulatory requirements. |
| Reporting | Report adverse events within 24 hours of receipt. |
Key Performance Indicators:
- Efficient and high-quality clinical trial execution.
- Proactive risk mitigation and operational planning.
- Consistent clinical data review aligned with quality standards.
- High-quality contributions to clinical trial documentation.
Minimum Requirements:
- Experience:
- Cross-cultural experience in clinical research.
- Operations management and clinical trial expertise.
- Skills:
- Knowledge of clinical trial protocols and data integrity.
- Strong project management and collaboration abilities.
- Languages: Proficiency in English is required.
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Meta Description:
Join Novartis as a Clinical Data Specialist I, managing trial data and collaborating with cross-functional teams.