Clinical Project Manager

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 company’s core values. Key Responsibilities: Research and prepare clinical elements of regulatory submission documents on behalf of client companies, including but not limited to CPSPs, IB’s & Annex XIV submissions, Study risk determination requests, IDE submissions, and 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. Undergraduate degree in biological sciences or other related scientific subject. Minimum 3+ years of 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 in 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 the job is on-site. Postgraduate degree in biological sciences or other related scientific subject Prior experience working in a rapid-growth, SME environment. Experience in 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 in risk management and CAPA systems. #J-18808-Ljbffr