Resumen
As a core member of the Clinical Trial Team (CTT), the main purpose of this position is accountability for vendor service delivery at the study level to independently manage all clinical vendor related aspects of global clinical trial(s).
#LI-HYBRID
About the Role
- Close interaction and collaboration with study team lead and study team members during study lifetime
- Review of vendor related protocol sections during protocol development
- Manage interface with vendors in cooperation with vendor partner functions
- Quote/proposal review in collaboration with procurement, support contract
negotiations - Contribute to the development of vendor contract amendments and accountable for vendor cost control, budget review, invoice reconciliation and PO close-out
- Vendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trial
- Cover all vendor activities after study start-up and all categories not covered by VSMs during start-up
- Initiate/co-ordinate vendor kick-off meeting for categories not covered by VSMs
- Attend vendor kick-off meeting for VSM supported categories
- Optimizing a frontloaded and timely study-start-up process, manage vendor-related activities for DB go live
- Perform user-acceptance testing (UAT) for eCOA and IRT
- Drive and monitor central vendor-related activities for site activation, compile Final Protocol Package (FPP) required documents centrally, monitor site activation progress and address related issues and risk
- Creates and maintains vendor-related risk maps with contingency plan for
documentation in FIRST - Interact and collaborate with Data Ops, reviews vendor-related cycle times (e.g. DTS finalization, data transfers, DBL)
Minimum Requirements:
- 5+ years working experience and excellent knowledge of the clinical operation processes and vendor management
- Excellent knowledge of GxP and ICH regulations
- Very good knowledge of clinical trial design and mapping to supplier requirements
- Thorough and technical understanding of Novartis specifications for supplier provided services
- User Acceptance testing for eCOA and IRT
- Site collaboration and site activation
- Vendor management; outsourcing, contracting, sourcing, of clinical services
- Results-driven: demonstrated ability of completing projects on time
- Ability to work in cross-functional teams and a matrixed environment
- Strong influencing and negotiation skills
- Good written and oral communications skills
- Very good problem-solving skills
- Demonstrated willingness to make decisions and to take responsibility for such
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: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about 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.
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.
