Trial Vendor Startup Manager - FSP

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!

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