Company
ImagingOperationsManager,ClinicalStudies
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“Imaging Operations Manager, Clinical Studies. Skills: operational implementation of imaging strategy, vendor service delivery, risk assessment, contingency planning, vendor management, clinical operations, GxP, ICH regulations, clinical trial design, stakeholder management. Operational implementation of the imaging strategy for assigned clinical studies. Support the full study lifecycle and/or contribute directly to study sub-teams”
What You'll Achieve.
Enable a flawless and accelerated vendor service delivery at the trial start-up phase; Optimize a frontloaded and timely study start-up (SSU) process; Support a timely vendor database (DB)-go-live; Ensure vendors meet quality and service level standards in their service delivery for the trial
Industry & Context.
Proactively assess risk and conclude contingency plans; Root cause analysis; Problem solving; Solution generation
Requires regular presence on site
What They're Looking For.
Must Have
Fluent English, oral and written, Solid 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, Demonstrated leadership with supplier relationship service areas management and/or expert knowledge of specific, 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)
Nice to Have
Ideally in the category Imaging, New staff as applicable to specific category
What You'll Do.
Operational implementation of the imaging strategy for assigned clinical studies
Support the full study lifecycle and/or contribute directly to study sub-teams
Enable flawless and accelerated vendor service delivery at the trial start-up phase
Support implementation of defined category strategies and service standardization
Proactively assess risk and conclude contingency plans to de-risk study startup and milestones
Reviewing of the vendor and category related specific sections of the protocol
Contributing to development of Study Specification Worksheet (SSW)
Facilitate bid process and selection of Vendors
Reviewing Quote/Proposal review in collaboration with procurement (and vendor)
Supporting contract negotiations and budget review
Co-ordinating vendor kick-off meeting
Managing the imaging vendor interface with the study team
Leading vendor meetings
Driving preparation of key documents
Tracking adherence of critical vendor milestones
Ensuring changes to protocol or study designs are consistently shared with vendors
Incorporating changes into supplier budgets
Supports amendment of vendor contracts with Procurement team
Optimizing a frontloaded and timely study start-up (SSU) process
Supporting a timely vendor database (DB)-go-live
Monitoring vendor service excellence at study level
Ensuring vendors meet quality and service level standards in their service delivery for the trial
Pro-actively creating and maintaining vendor related risk maps with contingency plan for documentation in company tool
Documenting issues identified with vendor oversight / performance
Implementing and monitoring corrective actions
Escalating issues if required to the Vendor Alliance Lead (VAL)
Supporting the implementation of standards
and processes for vendors at SSU for defined categories
Driving root cause analysis of supplier performance issues
Supporting practice leaders in improvement projects and learning loops
Participating in the onboarding
and training of new staff
Developing site and monitor training material
Attending/supporting training if needed
How You'll Work.
Team & Collaboration
Close collaboration with the Clinical Trial Team (CTT); Partnering across divisions with internal and external stakeholders; Collaboration with procurement; Collaboration with the VAL
Communication Scope
Fluent English, oral and written
Process & Methodology
process management, cross-functional coordination, vendor/stakeholder management, resource planning, continuous improvement
Full Job Description
**Job Description Summary** Location: Dublin, Ireland or London, UK. For UK applicants please apply to the following Job Requisition REQ-10076656 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 #LI-Hybrid **Job Description** ** _Key Responsibilities:_** * **Reviewing** of the vendor and category related specific sections of the protocol, ensuring 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, incl. reviewing Quote/Proposal review in collaboration with procurement (and vendor), supporting contract negotiations and budget review * **Co-ordinating** vendor kick-off meeting, managing the imaging vendor interface with the study team, including leading vendor meetings, driving preparation of key documents, tracking adherence of critical vendor milestones * **Ensuring** 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 * **Optimizing** a frontloaded and timely study start-up (SSU) process in support of a
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