Clinical Research Manager

3 weeks 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 join our team. As a key member of our regulatory affairs department, you'll play a crucial role in ensuring the success of our clinical research projects.

Key Responsibilities:

  • Lead the work of our company and project teams in providing specialized clinical research assistance to client companies, ensuring their expectations and interests are met.
  • Contribute to the formulation and implementation of short and medium-term Key Performance Indices/Indicators that measure success.
  • Research and prepare elements of clinical regulatory submission documents on behalf of client companies, including CTA's, Study risk determination requests, IDE submissions, and IRB/REC Submissions.
  • Contribute to the wider team's understanding of clinical operations requirements for investigational devices in the set-up, management, and conduct of device clinical investigations worldwide.
  • Prepare clinical affairs/operations quality management system audit reports and gap analyses on behalf of client companies.
  • Contribute to the preparation of global clinical research guidance documents and white papers.
  • Take advantage of professional networking opportunities to promote the company and its services to appropriate parties.
  • Identify and undertake continuing professional development linked to personal objectives to ensure ongoing awareness of current quality and regulatory standards.

About Us:

HIRANI is a leading provider of clinical research services, dedicated to delivering high-quality solutions that meet the needs of our clients. Our team is passionate about advancing medical science and improving people's lives through innovative research and development.



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