Medical Evidence and Execution Manager (Baja California Sur)

**Summary**:
- Contributes, with appropriate oversight, to all aspects of integral 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**:
- 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) **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.
- Collaborating across boundaries.
- Financial Management. **Skills**:
- NA. **Languages**:
- English. Division International Business Unit Pharmaceuticals Location Mexico Site INSURGENTES Company / Legal Entity MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V. Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No **Accessibility and accommodation**: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Postúlate en Kit Empleo: kitempleo.com.mx/empleo/5u58uc