Study Start-Up Specialist (Uxbridge)

PharmiWeb.jobs: Global Life Science Jobs; Maidenhead; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A global organization is seeking a Study Start-Up Specialist based in Uxbridge. This hybrid role entails leading clinical trial start-up activities and ensuring compliance with regulatory standards, contributing to impactful research in a collaborative environment. Candidates should possess significant experience in clinical research, along with strong organizational and communication skills, to manage multiple priorities effectively.

Benefits

Hybrid working model

Opportunities for career progression

Work on meaningful clinical trials

Qualifications

• Minimum 3 years of experience in clinical research.
• Prior experience with Health Authority and Ethics Committee submissions.
• Strong understanding of GCP/ICH Guidelines.

Responsibilities

• Lead and coordinate all aspects of study start-up.
• Manage regulatory submissions and oversight.
• Collaborate with internal study teams and stakeholders.

Skills

Organizational skills

Problem-solving

Communication

Critical thinking

Compliance

Education

Degree in Life Sciences or related field

Job description

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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.

Learn more about our EEO & Accommodations request here .

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Education and Training

• Industries

  Staffing and Recruiting

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