Summary
About the Role
Key Responsibilities:
- Develop country resource needs/expectations strategy and align with vendor line management (CRAs and other vendor resources). Establishes governance model
- Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times
- Escalates non-compliance, performance issues, competency gaps and/or needs to vendors
- 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 oversight of CRA oversight visit performance
- Supports Clinical Development Audit and FSP vendors for site audits and inspection
- In collaboration with SSO Clinical Project Manager (CPM), supports recruitment strategies and site performance by ensuring high quality and compliance of monitoring activities
- Ensure country FSP strategy is aligned with global and hub plans
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
- Demonstrated negotiation and conflict resolution skills
- Fast change adaptability to best partner & influencing with FSP vendor on fast changing landscape
- Trust and rapport building is a very important skill needed
- Good communication skills, ability to influence others & Relationship management
- Excellent communicator and presenter (oral and written)
- Good analytical thinking
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
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