Medical Evidence and Execution Manager

391263BR

May 30, 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:

• 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.

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International

Pharmaceuticals

Mexico

INSURGENTES

MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.

Research & Development

Full time

Regular

No

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Accessibility and accommodation

Novartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

391263BR

Medical Evidence and Execution Manager

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Research & Development International Mexico

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