摘要
About the Role
Key responsibilities:
Close interaction and collaboration with study team lead and study team members during study lifetime
Review of vendor related protocol sections during protocol development
Collaborate with Vendor startup manager to the development of Study Specification Worksheet (SSW) to facilitate bid process. If no VSM is assigned to the category, drive the SSW completion.
Manages interface with vendors in cooperation with vendor partner functions
Quote/proposal review in collaboration with procurement, support contract negotiations, if required
Contributes to the development of vendor contract amendments • 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
Covers all vendor activities after study start-up and all categories not covered by VSMs during start-up
Initiates/co-ordinates vendor kick-off meeting for categories not covered by VSMs
Attends vendor kick-off meeting for VSM supported categories
Optimizing a frontloaded and timely study-start-up process, manages vendor-related activities for DB go live
Performs user-acceptance testing (UAT) for eCOA and IRT
Drives and monitors central vendor-related activities for site activation, compiles Final Protocol Package (FPP) required documents centrally, monitors site activation progress and addresses related issues and risk
Creates and maintains vendor-related risk maps with contingency plan for documentation in FIRST
Manages system and portal user access for vendor, sponsor and site staff, maintain access logs
Uses Unified Vendor Portal (UVP) to manage vendor
Uses Clinical Insights to manage vendors and to achieve site readiness timelines
Plans and tracks supply delivery to sites and return of equipment from sites
Interacts and collaborates with Data Ops, reviews vendor-related cycle times (e.g. DTS finalization, data transfers, DBL)
Acts as escalation point for vendor-related query management
Follow-up with countries and hubs for their vendor-related risks and issues
Document issues identified with vendor oversight/performance in FIRST tool and implements and monitors corrective action
Essential requirements:
Bachelor degree or equivalent degree is required, with advanced degree preferred.
Fluent English (oral and written)
3+ 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
Excellent interpersonal skills (team player)
Proven networking skills and ability to share knowledge and experience amongst colleagues.
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 and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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.
