Summary
About the Role
Key Responsibilities
- Support country SSU strategy in collaboration with key stakeholder and ensure timely start-up activities from country allocation until Green Light.
- Collaborate with local IRBs/IECs and Health Authorities as necessary and prepare IRB/IEC submission packages and review Informed Consent Forms.
- Coordinate timely responses to deficiency letters and reportable events and ensure quality and compliance of country Trial Master File documents in study start-up.
- Implement innovative and efficient processes in line with Novartis strategy and support study feasibility and lead site selection.
- Oversee local vendor performance and ensure "Green Light" readiness and achieve start-up timelines and quality execution.
- Lead local SSU team meetings and develop site initiation plans and collaborate with the global study team as required.
Essential Requirements:
- Degree in a scientific or health discipline preferred.
- Minimum 5 years of clinical trial operations experience.
- Strong project management and problem-solving skills.
- Understanding of international drug development process and regulations.
- Excellent communication and negotiation skills.
- Ability to work effectively in a matrixed environment.
- Fluent in written and spoken English, local language as needed.
You’ll receive:
You'll have countless opportunities to develop, whether it’s up, across or outside your comfort zone. We offer you a challenging, international, interdisciplinary and enjoyable work environment. Investment in people is a priority for Novartis including your well-being. We offer a range of possibilities for personal development and career opportunities within a network of bright and curious minds. We offer you a competitive salary and benefit package.
Why Novartis?
Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. As part of our around 1800 employees in Belgium and Luxembourg, you can be part of an amazing team changing people’s lives. Together, we are reimagining medicine. Join us in extending and improving people’s lives.
Learn more here and discover some of the stories of who might become one of your future colleagues: https://www.novartis.com/be-nl/jobs & https://www.novartis.com/be-fr/emploi
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
