Imaging Operations Manager, Clinical Studies

Job Description Summary

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 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 there also 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 templates tools and processes for vendors at SSU for defined categories in collaboration with the VAL. Driving root cause analysis of supplier performance issues and look for trending supporting practice leaders in improvement projects and learning loops

• Participating in the onboarding mentoring and training of new staff as applicable to specific category

• In partnership with the vendor developing site and monitor training material and attend/support training if needed

Minimum Requirements:

• Advanced degree in science or business with experience in trial vendor management ideally in the category Imaging

• Fluent English oral and written

• Solid working experience and excellent knowledge of the clinical operation processes and vendormanagement

• Excellent knowledge of GxP and ICH regulations

• Expert knowledge of clinical trial design and mapping to supplier requirements

• Demonstrated leadership with supplier relationshipservice areasmanagement and/or expert knowledge of specific

• Demonstrated partnering across divisions with internaland external stakeholders

• Demonstrated root cause analysis problem solving andsolution generation skills

• Knowledge of key deliverables that impact green lightmilestones and vendor readiness

• Experience in outsourcing contracting sourcing of clinical services with Vendor/CROs (RFP RFQcontracting)

Skills Desired