391263BR
Jul 04, 2024
Mexico
Summary
-Contributes, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team, Contributes to operational excellence through process improvement and knowledge sharing
About the Role
Major accountabilities:
Work Experience:
- Contributes to all operational trial deliverables, according to timelines, budget, operational procedures, quality /compliance and performance standards.
- Conduct study start-up activities such as overseeing protocol development, CRF development, Informed Consent Form development.
- May identify new sites for clinical trials; analyze capability & make recommendation for trial inclusion.
- Ensuring proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.
- Responsible for education, implementation & compliance to standards (SOPs) & best practices for clinical operations 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)
- 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
Work Experience:
- Operations Management and Execution.
- Project Management.
- Collaborating across boundaries.
- Financial Management.
- NA.
- English.
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International
Innovative Medicines
Mexico
INSURGENTES
MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.
Research & Development
Full time
Regular
No
