Vendor Start Up Manager - IRT - FSP - Remote

TN United Kingdom; Uxbridge; Remote; GBP 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a Vendor Start-up Manager to enhance vendor service delivery during the trial start-up phase. This role involves overseeing vendor management, ensuring compliance with regulatory standards, and optimizing study start-up processes. The ideal candidate will have a strong background in clinical operations, excellent problem-solving skills, and the ability to collaborate effectively with internal and external stakeholders. Join a dynamic team dedicated to excellence in clinical trials and make a significant impact in the healthcare sector.

Qualifications

• 3+ years of experience in clinical operations and vendor management.
• Strong knowledge of GxP and ICH regulations.

Responsibilities

• Manage vendor service delivery during trial start-up phases.
• Ensure compliance and quality standards are met by vendors.
• Conduct risk assessments and develop contingency plans.

Skills

Strategic skills

Organizational knowledge

Project management

Problem solving

Negotiation

Conflict resolution

Influencing skills

Proficient in English

Education

Bachelor's degree in a relevant field

Job description

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Client:

Parexel

Location:

Uxbridge, United Kingdom

Job Category:

Customer Service

EU work permit required:

Yes

Job Reference:

8e989d0ae209

Job Views:

2

Posted:

13.04.2025

Expiry Date:

28.05.2025

Job Description:

When our values align, there's no limit to what we can achieve.

Parexel FSP has an exciting opportunity for a Vendor Start-up Manager to join our single sponsor dedicated team, based in either the UK, Ireland, Italy, Serbia or Romania.

Job Summary:

The VSM enables a flawless and accelerated vendor service delivery at the trial start-up phase and supports implementation of defined category strategies and service standardization and ensures compliance through the life of the studies assigned. This role proactively assesses risk and concludes contingency plans to de-risk study start-up and beyond.

Each VSM is category aligned, this role is aligned to manage IRT services/Vendors.

Key Accountabilities:

1. Reviewing of the vendor and category related specific sections of the protocol, ensure vendor expertise is leveraged when refining specifications towards Final Protocol.
2. Contributing to development of Study Specification Worksheet (SSW) to facilitate bid process and selection of Vendors.
3. Quote/Proposal review in collaboration with procurement (and vendor). If required, support contract negotiations.
4. Vendor budget review of final quotes.
5. Accountable for Vendor cost control, budget review, invoice reconciliation and PO close-out.
6. Supports program overview by providing study demands to VCE.
7. Ensures all submission documents are provided by vendor, as required, to countries participating in a study.
8. Works closely with trial and monitoring teams to understand site requirements for study participation.
9. Ensures changes to country and site plans are consistently shared with vendors and VCE for start-up, resupply and close out. Supports amendment of vendor contracts with Procurement team.
10. Optimizing a frontloaded and timely study start-up process in support of a timely site readiness.
11. Vendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trial.
12. Acts as escalation point for vendor-related query management.
13. Pro-actively creates and maintains vendor related risk maps with contingency plan for documentation.
14. Follow-up with countries and Hubs for their vendor-related risks and issues.
15. Document issues identified with vendor oversight/performance in sponsor’s internal tool and implements and monitors corrective actions. Escalates issue if required to the Vendor Category Expert VCE.
16. Drive root cause analysis of supplier performance issues and look for trending.
17. Supports the implementation of standards, templates, tools, and processes for vendors for defined categories in collaboration with the VCE.
18. Supports practice leaders in improvement projects and learning loops.
19. Collaborate across the sponsor’s departments to provide data for vendor qualification efforts.
20. Review and approve invoices against activity.
21. In partnership with the vendor, develop site and monitor training material, and attend/support training if needed.

Skills:

• Demonstrated strategic skills; organizational knowledge; advanced planning and project management skills, as well as an advanced understanding of business processes.
• Partnering skills with internal and external stakeholders.
• Strong problem solving, negotiation, deadline driven and conflict resolution abilities.
• Strong influencing skills and timeline driven.
• Proficient in written and spoken English.

Knowledge & Experience:

• 3+ years 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.
• Experience working with and Managing Patient Recruitment and Retention vendors/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 IRT Vendors.
• Specific category expertise – ideally experience of global equipment supply and/or radiation, but this is not a necessity.