Imaging Operations Manager, Clinical Studies

About this role

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

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 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)
• Skills Desired