Imaging Operations Manager, Clinical Studies

Overview

As Imaging Operations Manager (IOM) you will be responsible for the operational implementation of the imaging strategy for assigned clinical studies in close collaboration with the Clinical Trial Team (CTT). You may support the full study lifecycle and/or contribute directly to the study sub-team(s). In this role you will enable a flawless and accelerated vendor service delivery at the trial start-up phase and support implementation of defined category strategies and service standardization. You proactively assess risk and conclude contingency plans to de-risk study startup and milestones. This position is part of VP&G (Vendor Partnership & Governance) Vendor Alliance Imaging team and reports directly to the Vendor Alliance Lead Associate Director. It is a hybrid position and requires regular presence on site.

Responsibilities

• Review vendor and category related sections of the protocol, ensuring vendor expertise is leveraged when refining specifications towards the Final Protocol
• Contribute to development of the Study Specification Worksheet (SSW) to facilitate bid processes and the selection of vendors; review quotes/proposals in collaboration with procurement, support contract negotiations and budget review
• Coordinate vendor kick-off meetings, manage the imaging vendor interface with the study team, lead vendor meetings, drive preparation of key documents, and track adherence to critical vendor milestones
• Ensure changes to protocol or study designs are shared with vendors and incorporated into supplier budgets, timelines, and specifications; support amendment of vendor contracts with Procurement
• Optimize frontloaded and timely study start-up (SSU) processes to support a timely vendor database go-live
• Monitor vendor service excellence at the study level, ensuring vendors meet quality and service level standards in their delivery
• Proactively create and maintain vendor-related risk maps with contingency plans; document issues identified with vendor oversight/performance, implement and monitor corrective actions, and escalate as required to the Vendor Alliance Lead
• Support the implementation of standards, templates, tools, and processes for vendors at SSU for defined categories; drive root cause analysis of supplier performance issues and support improvement projects and learning loops
• Participate in onboarding, mentoring, and training of new staff as applicable to the category
• In partnership with the vendor, develop site and monitor training material and attend/support training as needed

Qualifications

• Advanced degree in science or business with experience in trial vendor management, ideally in the Imaging category
• Fluent English, both oral and written
• Solid working knowledge of clinical operations processes and vendor management
• Excellent knowledge of GxP and ICH regulations
• Expert knowledge of clinical trial design and mapping to supplier requirements
• Demonstrated leadership in supplier relationship management and/or expert knowledge of specific areas
• Proven ability to partner across divisions with internal and external stakeholders
• Strong root cause analysis, problem solving, and solution generation skills
• Knowledge of deliverables that impact green-light milestones and vendor readiness
• Experience in outsourcing, contracting, and sourcing of clinical services with Vendors/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!

Disclaimer: Some restrictions on flexible working options may apply and will be discussed during interview if applicable. You’ll receive benefits and rewards as described in the Novartis Life Handbook. 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. Hiring decisions are based on qualifications for the position, regardless of gender, ethnicity, religion, sexual orientation, age or disability. If you would like to request accommodations for applicants with disabilities, inform us in advance.