Novartis is a leading global pharmaceutical company committed to reimagining medicine to improve and extend lives. With a strong focus on innovation, Novartis delivers high-quality healthcare solutions worldwide. The Hyderabad office is a key hub for clinical data management, driving cutting-edge research and drug development.
Detailed Job Description
Job Title: Senior CDM/DBD (Clinical Data Management/Database Development)
Location: Hyderabad (Office)
Job Type: Full-time
Requisition ID: REQ-10058543
Posted: Today
Key Responsibilities:
- Lead Data Management (DM) activities for clinical trials, ensuring high-quality, timely, and cost-effective deliverables.
- Oversee database development, data provisioning, and CDDRA (Clinical Data and Document Review and Approval) processes.
- Ensure compliance with Good Clinical Practices (GCP) and data-handling regulations.
- Collaborate with cross-functional teams to review protocols, reports, and statistical analysis plans.
- Manage data load, transfer, and conformance to NCDS (Novartis Clinical Data Standards).
- Drive process improvements, training modules, and technology adoption for efficiency.
- Support audits, inspections, and quality control for data integrity.
- Generate data review listings, study status reports, and ensure consistency in DM documentation.
- Lead DAP (Data Analysis & Programming) activities for Phase I-IV clinical studies.
Key Performance Indicators (KPIs):
✅ High-quality, timely, and cost-efficient data management deliverables
✅ Zero critical audit findings related to DM
✅ Compliance with Novartis policies and regulatory standards
✅ Positive stakeholder and project feedback
Eligibility & Skills Required
Minimum Requirements:
- Work Experience:
- Strong background in Clinical Data Management (CDM)
- Experience in Project Management & Cross-Cultural Collaboration
- Technical Skills:
- Data Governance | Data Integrity | Data Quality
- Database Management | Data Science | Waterfall Model
- Languages: Fluent in English
Preferred Skills:
- Experience in pharmaceutical drug development
- Knowledge of NCDS, CDDRA, and DAP processes
- Ability to lead training & process improvement initiatives
Employee Benefits
Novartis offers a competitive benefits package, including:
- Health & wellness programs
- Professional development opportunities
- Flexible work policies
- Performance-based incentives
