Trial Vendor Startup Manager - FSP
Primary Location: United Kingdom, Remote Additional Locations: Ireland, Remote; Italy, Remote; Poland, Remote; Romania, Remote; Spain, Remote Job ID R0000042692 Category Procurement
About this Role
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
#LI-REMOTE
JOBS FOR YOU
There is no jobs to view
You currently have no saved jobs to view.
Make sure to accept the Functional cookies to enable this module to display saved job links. You will be able to review them here when you revisit this page..
More Than A Job
