Study Start-Up Specialist (Uxbridge)

Fortrea; Maidenhead; On-site; GBP 35,000 - 55,000; Full time

Job summary

An innovative organization is seeking a Study Start-Up Specialist to drive impactful clinical trials. This hybrid role allows you to work closely with a top-tier sponsor, leading study start-up activities and regulatory submissions. You'll be part of a dedicated team, ensuring compliance with GCP/ICH guidelines while managing multiple priorities. Enjoy a collaborative environment in a modern office, with opportunities for career progression. If you're passionate about making a difference in clinical research and thrive in a dynamic setting, this role is perfect for you.

Benefits

hybrid working model

career progression opportunities

collaborative office environment

Qualifications

• Minimum 3 years of industry experience in clinical research, including start-up activities.
• Strong understanding of GCP/ICH Guidelines and the UK regulatory environment.

Responsibilities

• Lead and coordinate all aspects of study start-up, from site identification to activation.
• Manage Health Authority and Ethics Committee submissions and ensure compliance.

Skills

clinical research

study start-up activities

Health Authority submissions

Ethics Committee submissions

organizational skills

critical thinking

communication skills

risk analysis

problem-solving

Education

3+ years of clinical research experience

Job description

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:

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

What You Bring:

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

Why Apply?

1. Work directly with a top-tier sponsor on meaningful clinical trials.
   
2. Enjoy a hybrid model - 50% based in a collaborative, modern office in Uxbridge.
   
3. Be part of a dedicated, professional team with opportunities for career progression.
   
4. 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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