Summary

Primary contact for Functional Service Providers (FSP) and other monitoring service vendors to assure adequate quality of the services & performance in Novartis sponsored clinical trials. Oversee monitoring performance targets per defined performance and quality indicators including site recruitment, commitments, data health metrics and document health metrics. Responsible for resource management, aligns with FSP line managers for CRAs to allocation of trials, sites.

About the Role

Major accountabilities:

• Primary point of contact for country FSP line management and other vendors providing monitoring services
• Develops FSP resourcing strategy and aligns it with vendor line management (for CRAs and other vendor resources)
• Oversees country trial site activation, enrolment, data flow and timeline commitments are delivered per established trial objectives.
• Oversees monitoring quality, timely data entry and issue resolution including of CRA oversight visit performance
• Collaborates with CRA Manager and other internal stakeholders for country resource strategy. Hiring, training, development and retention of assigned internal CRAs if any.

Essential Requirements

• Minimum 7 years' experience in clinical research - planning/executing and/or monitoring clinical trials• Experience and evidence of team leadership capabilities• Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution
• Degree in scientific or health discipline required and advanced degree preferable
• Good communication and negotiation skills, ability to influence others
• Stakeholder management capabilities with demonstrated capability to problem solve and mediate complex issues
• Good understanding of the Risk Based Monitoring process and requirements
• Ability to anticipate potential issues and take appropriate actions
• Excellent coaching capability to best support and solve problem, anticipate potential risk, issues and take appropriate actions. Drive right mindset and behavior to team members.

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