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: http://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. http://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: http://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? http://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: http://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://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.