Join to apply for the Clinical Project Manager role at ARC Regulatory.
Location: Belfast, Northern Ireland, United Kingdom
Employment Type: Full-time
Seniority Level: Mid-Senior level
About ARC Regulatory
ARC Regulatory is a Belfast-based Clinical Research Organisation dedicated to expediting access to precision medicine clinical trials globally. We specialize in delivering compliance excellence for companies in the sector of precision medicine, supporting leading pharmaceutical R&D companies in implementing unapproved diagnostics in clinical development programs. Our team covers IVD regulatory compliance, study design, approvals, quality assurance, and clinical management, ensuring studies are conducted in compliance with global GCP standards. We have developed ARC360, a SaaS platform transforming access to regulatory intelligence and study-specific information for in vitro diagnostics.
Job Purpose
To contribute significantly to project teams by developing and delivering global clinical compliance solutions that meet and exceed client objectives, utilizing a high-standard approach to clinical research and stakeholder satisfaction.
Key Responsibilities
* Research and prepare clinical elements of regulatory submission documents (e.g., CPSPs, IBs, Annex XIV submissions, Study risk requests, IDE submissions, IRB/REC submissions).
* Assist in understanding clinical operations requirements for investigational IVDs.
* Prepare clinical affairs/operations quality management system audit reports and gap analyses.
* Contribute to the development of guidance documents, conference materials, webinars, and white papers.
* Manage project budgets and track progress.
* Design and deliver client presentations.
* Participate in company culture initiatives.
Essential Criteria
* Undergraduate degree in biological sciences or related field.
* Minimum 3+ years of IVD clinical affairs/R&D experience or 3-year post-doc in a relevant area.
* Knowledge of clinical performance studies in accordance with EU IVDR and relevant regulations.
* Experience with IRB/IEC submission requirements.
* Ability to generate and review clinical study documents.
* Proof of Right-to-Work in the UK.
* Ability to commute daily to Belfast.
Desirable Criteria
* Postgraduate degree in biological sciences or related field.
* Experience in a rapid-growth SME environment.
* Knowledge of clinical research regulatory requirements for companion diagnostics in the US.
* Experience in strategic planning, risk management, CAPA systems, eDC, eTMF platforms, and NHS R&D.
Skills
Clinical Monitoring, Clinical Research
Benefits
* Free Car Parking
* Competitive salary
* Private Health Insurance
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