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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
TEst Hello
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.