Medical Evidence and Execution Manager

hace 3 semanas


Insurgentes, México Novartis A tiempo completo

**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**:

- 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.


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