About the Role
Major Accountabilities:
- Contributes to all operational/clinical trial deliverables that are in scope of the specific JD, according to timelines, budget, operational procedures, quality/compliance, and performance standards.
- Conduct/Contribute to study start-up activities such as overseeing protocol development, CRF development, and Informed Consent Form development.
- May/may not be involved in identifying new sites for clinical trials; analyze capability and make recommendations for trial inclusion.
- Ensuring proper handling of all study conduct and close-out activities including but not limited to site close-out, final drug accountability, and audit readiness of Trial Master File documentation (if in scope of the specific JD).
- Responsible for education, implementation, and compliance with standards (SOPs) and best practices for clinical operations/clinical data review activities within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned.
- Reporting of technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt.
- Distribution of marketing samples (where applicable).
Key Performance Indicators:
- 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.
Minimum Requirements:
Work Experience:
- Operations Management and Execution.
- Project Management.
- Financial Management.
- Collaborating across boundaries.
Skills:
- Trial Planning and Feasibility.
- Over The Counter Product Development.
- Post Authorization Data Safety.
- Regulatory Strategy.
- Clinical Trial Set-up, Management & Conduct.
Languages:
- English.
