Senior / Clinical Trial Manager page is loaded

Senior / Clinical Trial Manager

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• We are Built by You. Your ideas influence the way we work, and your voice matters here.

• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
  

Together, we are Built for Biotech. Join us and build your future here.

What you'll be doing:

• Oversee end-to-end clinical trial execution with a focus on maintaining inspection readiness throughout the study lifecycle

• Lead cross-functional readiness assessments and corrective action planning to address gaps prior to inspections

• Champion Trial Master File (TMF) quality and oversight; drive timely, complete, and accurate document management

• Coordinate and participate in mock internal and external audits and regulatory inspections (MHRA, EMA, FDA)

• Develop and manage study-specific inspection readiness plans, training, and compliance tracking

• Collaborate with Quality Assurance, Clinical Quality, and Regulatory Affairs to ensure audit/inspection deliverables are met

• Conduct root cause analyses and implement corrective and preventive actions (CAPAs) when issues are identified

• Support and train internal study team and vendors on best practices for audit readiness and GCP adherence

What we are searching for:

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field

• Minimum 10 years of clinical research experience, including 2+ years of trial management with inspection readiness responsibilities

• Proven experience in inspection readiness for global Phase II/III studies and / or supporting MHRA, EMA, or FDA inspections (pre-approval or routine)

• In-depth knowledge of ICH-GCP, EU/UK Clinical Trial Regulation (CTR), and US FDA regulatory frameworks

• Familiarity with TMF reference models, CTMS, and eTMF systems (e.g., Veeva, Trial Interactive, Wingspan)

• Experience with CAPA implementation and inspection follow-up activities

This position will be working for our Functional Services business and is offered on a fixed term contract basis, duration up to 9 months and with an immediate start.