About the Role
Your responsibilities include, but are not limited to:
• 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.
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• 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
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
• 8+ 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
769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team's 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
Division
Development
Business Unit
GCO GDD
Location
India
Site
Hyderabad, AP
Company / Legal Entity
Nov Hltcr Shared Services Ind
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No