Company and Employer
* Company: JR UK
* Client/Employer: ARC Regulatory Ltd
Location and Salary
Belfast – Salary: £ DOE
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.
Key Responsibilities
* Study design, strategy, planning (timeline, resources and budget management).
* Coordinating clinical operational activities with internal stakeholders and clients, including pharma companies and central testing laboratories conducting the studies.
* Development and/or review of associated documentation 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 the 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, and 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 authorities.
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.
* Must be able to commute daily to Belfast as the job is on‑site.
Desirable Criteria
* Postgraduate degree in biological sciences or other related scientific subject.
* Prior experience working in a rapid growth, SME environment.
* Specific experience within oncology, IHC, NGS or molecular CDx.
Benefits
* Private Medical
* Free Car Parking
* Employee Referral Scheme
Equal Opportunity Statement
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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