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

• 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

Apply now to join a passionate team where your expertise drives innovation and improves lives.

Learn more about our EEO & Accommodations request here .