Senior Clinical Project Manager (IVD/CDx)
ARC Regulatory seeks applications from like-minded, culturally aligned and ethically strong clinical research professionals. Ideally, you have experience in in vitro diagnostic and/or companion in vitro diagnostic clinical study development, oversight, and management. Join the ARC team to be at the centre of cutting-edge science and engineering innovations that lead to real improvements in peoples’ lives. ARC – From Lab to Life. The role: Lead the work of the company and project teams in the provision of specialised clinical research assistance to client companies, ensuring expectations and interests are met. Contribute to the formulation and implementation of the short and medium-term Key Performance Indices/Indicators that allow for measurement of success. Research and prepare elements of clinical regulatory submission documents on behalf of client companies, including but not limited to CTA’s, Study risk determination requests, IDE submissions, IRB/REC Submissions. Contribute to the wider team’s in understanding the clinical operations requirements for an investigational device in the set-up, management & conduct of device clinical investigations worldwide. Prepare clinical affairs/operations quality management system audit reports and gap analyses on behalf of client companies. Work to manage and prioritise actions relevant to direct reports workload, internal process development and client deliverables. Contribute to the preparation of global clinical research guidance documents and white papers. Take advantage of professional networking opportunities in order to promote the company and its services to appropriate parties. Design and deliver formal client presentations, including proposed solutions. Identify & undertake continuing professional development linked to personal objectives to ensure ongoing awareness of current quality and regulatory standards. Any other duties, within reason and capability, as determined by the Management.
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ARC Regulatory seeks applications from like-minded, culturally aligned and ethically strong clinical research professionals. Ideally, you have experience in in vitro diagnostic and/or companion in vitro diagnostic clinical study development, oversight, and management. Join the ARC team to be at the centre of cutting-edge science and engineering innovations that lead to real improvements in peoples’ lives. ARC – From Lab to Life. The role: Lead the work of the company and project teams in the provision of specialised clinical research assistance to client companies, ensuring expectations and interests are met. Contribute to the formulation and implementation of the short and medium-term Key Performance Indices/Indicators that allow for measurement of success. Research and prepare elements of clinical regulatory submission documents on behalf of client companies, including but not limited to CTA’s, Study risk determination requests, IDE submissions, IRB/REC Submissions. Contribute to the wider team’s in understanding the clinical operations requirements for an investigational device in the set-up, management & conduct of device clinical investigations worldwide. Prepare clinical affairs/operations quality management system audit reports and gap analyses on behalf of client companies. Work to manage and prioritise actions relevant to direct reports workload, internal process development and client deliverables. Contribute to the preparation of global clinical research guidance documents and white papers. Take advantage of professional networking opportunities in order to promote the company and its services to appropriate parties. Design and deliver formal client presentations, including proposed solutions. Identify & undertake continuing professional development linked to personal objectives to ensure ongoing awareness of current quality and regulatory standards. Any other duties, within reason and capability, as determined by the Management.
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