Résumé
About the Role
Responsibilities:
- Work in close collaboration with the Vendor Program Manager (VPM) and CRO during study startup phase to optime a front loaded and timely study start-up process.
- Contribute to the development of Study Specification Worksheet (SSW) to facilitate bid process and selection of Vendors.
- Review vendor proposal / budget in collaboration with procurement (and vendor). If required, support contract negotiations.
- Ensure changes to protocol or study designs are consistently shared with vendors and incorporated into supplier budgets, timelines, and specifications. Support amendment of vendor contracts with Procurement team.
- Vendor service excellence at study level, ensuring vendors meet quality and service level standards in their service delivery for the trial.
- Pro-actively create and maintaining vendor related risk maps with contingency plan for documentation.
- Document issues identified with vendor oversight / performance and implementing and monitoring corrective actions. Escalate issue if required to the Vendor Category Expert (VCE).
Requirements:
- Bachelor degree in science and or business. Advance degree preferred.
- Demonstrated experience and knowledge of the clinical operation processes and vendor management.
- Excellent knowledge of GxP and ICH regulations.
- Expert knowledge of clinical trial design and mapping to supplier requirements.
- Demonstrated leadership with supplier relationship management and/or specific service areas.
- Experience partnering across divisions with internal and external stakeholders.
- Demonstrated root cause analysis, problem solving, and solution generation skills
- Knowledge of key deliverables that impact green light milestones and vendor readiness
- Experience in outsourcing, contracting, sourcing of clinical services with Vendor/CROs (RFP, RFQ, contracting).
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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.
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