ARC Regulatory
Clinical Study Lead
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About This Job
ARC Regulatory
Location: Belfast, Northern Ireland, United Kingdom
Work Mode: On-site
Industry: Biotechnology Research
Job Description
ARC's purpose is to expedite access to precision medicine clinical trials for patients globally. We fulfil our purpose through our dedicated team of experts with unparalleled domain knowledge, and the important relationships we have developed with our global clients.
We are a Belfast-based Clinical Research Organisation that specialises in delivering compliance excellence for companies in the precision medicine sector. We support many of the world's leading pharmaceutical R&D companies in implementing unapproved diagnostics in their clinical development programmes for patient selection or stratification, working as a strategic and integrated expert partner, taking full sponsor ownership of the IVD study being conducted in parallel with our clients' IND/IMP trial.
ARC's team of experts cover IVD regulatory compliance, study design and approvals, quality assurance including vendor due diligence and management along with a team of clinical research experts who manage the IVD study, ensuring it is conducted in compliance with local and global GCP, and that the biomarker data is robust and reliable.
Job Purpose
To be an integral member and Clinical Lead to project team(s) in the development and delivery of ARC’s Sponsor Delegation offering to client companies, ensuring that client objectives are met and always exceeded. This will require the utilisation of a platinum standard approach to clinical research project management, internal and external stakeholder satisfaction as well as an innate work ethic that is aligned with the company’s core values.
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Key Responsibilities
- Study design, strategy, planning (timeline, resources, and budget management)
- Coordinating clinical operational activities with internal stakeholders and clients, including pharma company and central testing laboratories conducting the studies
- Development and/or review of associated documentation including documents such as CPSP, CSP, investigator brochure, informed consent for devices, risk-based monitoring plan and reports, in compliance with relevant regulations, guidelines, and SOPs
- Client management, issue resolution, troubleshooting, and ongoing coordination between all relevant groups to maintain compliance to protocol, patient safety, and robust data collection and provision of regular updates to project progression
- Set up, manage, and track studies, supporting study completion within agreed timelines and budget
- Identify and enlist suitable study sites, and coordinate site management activities, with site audit, Site Qualification Visit, and study set up across USA, EU, and Asia/Pac regions
- Understanding and application of relevant regulatory requirements and ethical approvals for conducting studies (e.g., IVDR requirements for EU, FDA requirements for USA, GCP, ISO20915)
- Managing the study close out activities including essential documentation filing and completion between study testing site(s) and sponsor TMF, ethical and regulatory bodies notification of study close, study close out report
- Generation of clinical study reports and related documentation to submit to regulatory authorities, ethical review boards, and local agencies such as national competent authority
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Essential Criteria
- Undergraduate degree in biological sciences or other related scientific subject
- Minimum 3+ years clinical experience in an IVD device manufacturer; other devices or pharmaceutical experience in the capacity of device sponsor will be considered
- Demonstrable knowledge of regulatory requirements and industry practices (e.g., IVDR, FDA, GCP, ISO14155, ISO20916, ISO13485, and QMS design control)
- Experience of using TMF and/or eTMF and Smartsheet (or equivalent) software
- Experience of authoring clinical study documents (e.g., Clinical Strategy, Data Management Plan, CPSP, CSP, Investigator Brochure, Risk-based Monitoring Plan, Informed Consent Documents)
- Proof of Right-to-Work in the UK
“We are an equal opportunity employer; applications are welcome from all and appointment will be made on the basis of merit.”
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