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Job Reference:
cebc313d37ed
Job Views:
6
Posted:
05.05.2025
Expiry Date:
19.06.2025
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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:
* 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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