Summary
About the Role
- Oversees clinical program(s) across indications, executing medical strategy for development and marketed products in a defined therapeutic area.
- Conduct study start-up activities such as overseeing protocol development, CRF development, Informed Consent Form development.
- Is responsible for assuring aligned communication with Country/Cluster Clinical Research Associates, Managers and other key stakeholders on the execution and progress of the clinical studies.
- Identify new sites for clinical trials; analyze capability and make recommenda-tion for trial inclusion.
- Facilitate preparation and collection of site level documents; resolve problems as required.
- May execute site initiation and training.
- Implement total site management including monitoring visits, regulatory assess-ment, drug supply management and resolution of site problems to ensure compli-ance.
- Track trial execution milestones; identify problems; resolve issues and escalate as appropriate.
- May manage recruitment and execute contingency plans, as needed.
- Complete preparation/generation of study monitoring reports.
- May lead and chair local study team meetings, attend and participate in global clinical trial team meetings -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
- Deliver customer satisfaction results for internal and external customers -Delivery of Clinical Trials to quality standards and agreed timelines -Adherence to Novartis policy and guidelines and external regulations.
Work Experience:
- Managing Crises.
- Collaborating across boundaries.
- Functional Breadth.
- NA.
- English.
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