Clinical Data Specialist
Company: Novartis
Job ID: 393921BR
Date Posted: May 07, 2024
Location: India
Summary:
The Clinical Data Specialist contributes to various aspects of global clinical trials, ensuring they are conducted within schedule, budget, quality, compliance, and performance standards. This role may involve leading specific aspects of clinical trials and being a core member of the Clinical Trial Team, focusing on operational excellence through process improvement and knowledge sharing.
Major Accountabilities:
- Contribute to all operational/clinical trial deliverables as specified, adhering to timelines, budget, operational procedures, quality, compliance, and performance standards.
- Conduct or contribute to study start-up activities, including overseeing protocol development, CRF development, and Informed Consent Form development.
- May be involved in identifying new sites for clinical trials, analyzing capability, and making recommendations for trial inclusion.
- Ensure proper handling of all study conduct and close-out activities, including site close-out, final drug accountability, and audit readiness of Trial Master File documentation.
- Responsible for education, implementation, and compliance with standards (SOPs) and best practices for clinical operations/clinical data review activities within assigned clinical trials and programs, including sharing lessons learned.
- Report technical complaints, adverse events, or special case scenarios related to Novartis products within 24 hours of receipt.
- Distribute marketing samples where applicable.
Key Performance Indicators:
- Timely, efficient, and quality execution of assigned trials and related activities within budget and compliance with quality standards.
- Proactive operational planning with effective contingency and risk mitigation plans.
- Adherence to Novartis policy, guidelines, and external regulations.
Skills:
- Trial Planning and Feasibility.
- Over The Counter Product Development.
- Post Authorization Data Safety.
- Regulatory Strategy.
- Clinical Trial Set-up, Management & Conduct.
Languages:
- English