Senior Clinical Project Manager (IVD/CDx)

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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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