Summary
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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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Accessibility and accommodation
Novartis is committed to working with and providing 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.
