Clinical Project Manager

16 hours ago

Belfast, United Kingdom Arc Regulatory Ltd Full time

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.
To further support our growing client base and to expedite patient access to life-saving experimental medicines, ARC has developed and launched our SaaS platform, ARC360.
ARC360 is transforming how organisations access regulatory intelligence and tailor study-specific information for using in vitro diagnostics to select and manage patients in IND trials.
Powered by cutting-edge technologies and supported by a team of regulatory, quality, and clinical operations experts, ARC360 is designed to accelerate the initiation of complex clinical trials.
Job Purpose To be an integral member and significant contributor to project team(s) in the development and delivery of global clinical compliance solutions to client companies, ensuring that client objectives are met and exceeded at all times.
This will require the utilisation of a platinum standard approach to clinical research, internal and external stakeholder satisfaction as well as an innate work ethic that is aligned with the companys core values.
Key Responsibilities: Research and prepare clinical elements of regulatory submission documents on behalf of client companies, including but not limited to CPSPs, IBs & Annex XIV submissions, Study risk determination requests, IDE submissions, IRB/REC Submissions.
Assist wider team in understanding the clinical operations requirements for an investigational IVD in the set-up, management & conduct of IVD clinical investigations worldwide.
Prepare clinical affairs/operations quality management system audit reports and gap analyses on behalf of client companies.
Contribute to the preparation and/or delivery of global clinical research guidance documents, conference presentations, webinars, white papers and other company-developed materials as required.
Ongoing project budget management and tracking.
Design and deliver formal client presentations, including proposed solutions.
Contribute to ARC company culture initiatives to maintain a positive and engaging workforce.
Essential Criteria: Undergraduate degree in biological sciences or other related scientific subject.
Minimum 3+ years IVD medical device clinical affairs/R&D experience in a similar role or 3-year post-doc experience in a relevant research subject.
Demonstrable awareness of the requirements of clinical performance studies in accordance with the EU IVDR, as well as relevant regulations (eg: ISO 20916, 21 CFR).
Demonstrable awareness of IRB/IEC (ethics) submission requirements.
Experience of generating and reviewing documents relevant to clinical studies (eg: Strategy, Clinical Protocol, Monitoring Plans, Monitoring Reports).
Proof of Right-to-Work in the UK.
Must be able to commute daily to Belfast as 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.
Experience of clinical research regulatory requirements for companion diagnostics in the US.
Strategic planning for IVD clinical studies, including identification and qualification of suitable clinical investigation sites.
Experience of risk management and CAPA systems.
Experience of eDC and eTMF platforms.
Experience of working with NHS R&D.
Skills: Clinical Monitoring Clinical Research Benefits: Free Car Parking competitive salary Private Health Insurance

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