Trial Vendor Startup Manager - FSP

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the world transform scientific discoveries into new treatments. We believe in our values, Patients First, Quality, Respect, Empowerment & Accountability. We are currently looking to recruit an experienced Trial Vendor Startup Manager (Start -Up Project Manager) to work in our innovative and successful Parexel FSP group which is a flexible outsourcing model that provides specialized functional services to biopharmaceutical companies, enhancing efficiency, agility, and strategic support in clinical trials. This position is available in the following EMEA locations - UK, Spain, Ireland, Poland, Romania and Italy and we offer fully remote (country stipulated) home based working. As the Trial Vendor Startup Manager (Trial Start -Up Project Manager) you will be responsible for providing technical expertise for a given vendor category during study startup to the Vendor Program Manager (VPM) and indirectly to the study start-up team. You will enable a flawless and accelerated vendor service delivery at the trial start-up phase and supports implementation of defined category strategies and service standardization. You will also proactively assess risk and conclude contingency plans to de-risk study startup. Accountabilities Interacts closely with the Vendor Program Manager to achieve study objectives specifically for its assigned categories: 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 submission documents from vendor, as requested by countries participating in a study Performs robust User Acceptance Testing (UAT) for eCOA and IRT 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 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. Supports the implementation of standards, templates, tools, and processes for vendors at SSU for defined categories Supports practice leaders in improvement projects and learning loops. Education Advanced degree in life sciences or business with equivalent direct clinical trial project management experience Languages: Fluent English communication skills, oral and written Experience/Professional requirements: Strong clinical project management experience including advanced level study start up work exposure with excellent knowledge of clinical operation processes and vendor management. Specific vendor category expertise – specifically such as Central Labs, eCOA/ePRO, IRT, Cardiac and Respiratory diagnostics, PR&R, Imaging reading. Hands on experience in User Acceptance testing (eCOA & IRT) specifically. Excellent knowledge of GxP and ICH regulations Expert knowledge of clinical trial design and mapping to supplier requirements Thorough and technical understanding of client 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) In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary and a benefits package including holiday, pension and other leading-edge benefits that you would expect with a company of this type. Apply today to begin your Parexel journey! #LI-LG2