Study Start-Up Specialist (Uxbridge)

Are you an experienced clinical research professional with a passion for start-up activities and regulatory submissions? We are hiring a Study Start-Up Specialist for a sponsor-dedicated role, offering the opportunity to work on impactful studies while being part of a global, innovative organization.

This is a hybrid role, with 50% of your time spent onsite in Uxbridge, so candidates must be based within a commutable distance.

In this position, you'll be fully integrated into the sponsor s clinical operations team, playing a pivotal role in initiating and supporting clinical trials across the UK.

Key Responsibilities:

• Lead and coordinate all aspects of study start-up, from site identification to activation
  
• Manage Health Authority and Ethics Committee submissions (including substantial amendments)
  
• Ensure completeness of Essential Documents and oversee regulatory documentation within the eTMF
  
• Support the preparation and review of Informed Consent Forms (ICFs) and Clinical Trial Package (CTP) documentation
  
• Collaborate with internal study teams, site staff, IRBs/ECs, and other stakeholders to meet trial timelines
  
• Contribute to feasibility and site selection processes
  
• Ensure compliance with ICH-GCP, local regulatory requirements, and sponsor SOPs
  
• Support inspection readiness and participate in audit/inspection activities when required
  
  

What You Bring:

• Minimum 3 years of industry experience in clinical research, including start-up activities
  
• Prior experience with Health Authority and Ethics Committee submissions in the UK
  
• Knowledge or experience with contract negotiation processes is desirable
  
• Strong understanding of GCP/ICH Guidelines and the UK regulatory environment
  
• Excellent organizational and planning skills, with the ability to manage multiple priorities
  
• Demonstrated ability to work independently and within cross-functional teams
  
• Proficient in critical thinking, risk analysis, and problem-solving
  
• Effective communication skills with internal and external stakeholders
  
• Detail-oriented with a focus on quality and compliance
  
  

Why Apply?

• Work directly with a top-tier sponsor on meaningful clinical trials
  
• Enjoy a hybrid model - 50% based in a collaborative, modern office in Uxbridge
  
• Be part of a dedicated, professional team with opportunities for career progression
  
• Make a real impact by contributing to life-changing research and trial delivery
  
  

Ready to make your next move in clinical research?
Apply now to join a passionate team where your expertise drives innovation and improves lives.

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