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Clinical Data Specialist
4 weeks ago
This job is part of Novartis, an inclusive employer and a member of the LGBTQ+ business community.
SummaryThe successful candidate will contribute to all aspects of global clinical trials, delivering study outcomes within schedule, budget, quality, compliance, and performance standards. They may lead specific aspects of global clinical trials and be a core member of the Clinical Trial Team, contributing to operational excellence through process improvement and knowledge sharing.
About the RoleMajor Accountabilities:- Contributes to all operational/clinical trial deliverables according to timelines, budget, operational procedures, quality/compliance, and performance standards.
- Conducts or contributes to study start-up activities, including overseeing protocol development, CRF development, Informed Consent Form development.
- May be involved in identifying new sites for clinical trials, analyzing capability, and making recommendations for trial inclusion.
- Ensures 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 to standards (SOPs) and best practices for clinical operations/data review activities within assigned clinical trials and clinical programs.
- Reports technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours.
- Distributes marketing samples (where applicable).
- Timely, efficient, and quality execution of assigned trials and trial-related activities within budget and in compliance with quality standards.
- Proactive operational planning with effective contingency and risk mitigation plans.
- Adherence to Novartis policy and guidelines and external regulations.
- Operations Management and Execution.
- Project Management.
- Financial Management.
- Collaborating across boundaries.
- Trial Planning and Feasibility.
- Over-the-Counter Product Development.
- Post-Authorization Data Safety.
- Regulatory Strategy.
- Clinical Trial Set-up, Management & Conduct.
- English.
