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Clinical Research Coordinator, Sr

2 months ago


Belfast, United Kingdom HIRANI Full time
Senior Clinical Project Manager (IVD/CDx)

At HIRANI, we're seeking a highly skilled and experienced Senior Clinical Project Manager to lead our IVD/CDx clinical study development, oversight, and management initiatives. As a key member of our team, you will be responsible for providing specialized clinical research assistance to client companies, ensuring their expectations and interests are met.

We offer a competitive salary range of $120,000 - $150,000 per annum, depending on experience. If you're looking for a challenging role that will allow you to utilize your expertise in clinical operations and regulatory affairs, please read on.

The Role:
  • Lead the work of company and project teams in providing clinical research assistance to client companies.
  • Contribute to the formulation and implementation of Key Performance Indices/Indicators that measure success.
  • Research and prepare elements of clinical regulatory submission documents, including CTA's, Study risk determination requests, IDE submissions, IRB/REC Submissions.
  • Contribute to the wider team's understanding of clinical operations requirements for investigational devices in device clinical investigations worldwide.
  • Prepare clinical affairs/operations quality management system audit reports and gap analyses.
  • Contribute to the preparation of global clinical research guidance documents and white papers.
  • Promote the company and its services through professional networking opportunities.
  • Undertake continuing professional development to ensure ongoing awareness of current quality and regulatory standards.