Imaging Operations Manager

This role will report to the Vendor Alliance Lead, the Imaging Operations Manager (IOM) is responsible for the operational implementation of the imaging strategy for assigned clinical studies in collaboration with the Clinical Trial Team (CTT). IOMs may support the full study lifecycle and/or contribute directly to the study sub-team(s).

The IOM enables a flawless and accelerated vendor service delivery at the trial start-up phase and supports implementation of defined category strategies and service standardization.  This role proactively assesses risk and concludes contingency plans to de-risk study startup and milestones.

The role can be based in London, UK or Dublin Ireland.

Major responsibilities:

Your responsibilities include, but are not limited to:

• Reviewing of the vendor and category related specific sections of the protocol, ensure vendor expertise is leveraged when refining specifications towards Final Protocol.
• Contributing to development of Study Specification Worksheet (SSW) to facilitate bid process and selection of Vendors.
• Quote/Proposal review in collaboration with procurement (and vendor). If required, support contract negotiations.
• Vendor budget review of final quotes.
• Co-ordinates vendor kick-off meeting and other vendor specific meetings.
• Collects Health Authority submission documents from vendor, as requested by countries participating in a study.
• Ensures changes to protocol or study designs are consistently shared with vendors and incorporated into supplier budgets, timelines, and specifications. Supports amendment of vendor contracts with Procurement team.
• Vendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trial.
• Pro-actively creates and maintains vendor related risk maps with contingency plan for documentation in FIRST.
• Document issues identified with vendor oversight / performance in FIRST tool and implements and monitors corrective actions. Escalates issue if required to the Vendor Alliance Lead (VAL).
• Drive root cause analysis of supplier performance issues and look for trending
• Supports the implementation of standards, templates, tools, and processes for vendors at SSU for defined categories in collaboration with the VAL
• Using Unified Vendor Portal (UVP) to manage vendor service delivery
• Manage the imaging vendor interface with the study team, including leading vendor meetings, driving preparation of key documents, tracking adherence of critical vendor milestones
• Provide category-specific technical input to internal data management activities (such as eCRF and DTS creation).
• In partnership with the vendor, develop site and monitor training material, and attend/support training if needed

What you'll bring to the role:

• Advanced degree in science or business with equivalent experience.
• 3 – 5 years working experience and excellent knowledge of the clinical operation processes and vendor management.
• Excellent knowledge of GxP and ICH regulations.
• Expert knowledge of clinical trial design and mapping to supplier requirements.
• Thorough and technical understanding of Novartis specifications for supplier provided services.
• Demonstrated leadership with supplier relationship management and/or expert knowledge of specific service areas.
• Demonstrated partnering across divisions with internal and external stakeholders.
• Demonstrated root cause analysis, problem solving, and solution generation skills.
• Knowledge of key deliverables that impact green light milestones and vendor readiness.
• Experience in outsourcing, contracting, sourcing of clinical services with Vendor/CROs (RFP, RFQ, contracting)
• Specific category expertise – Imaging.