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
A day in the life of a Clinical Project Manager at ARC includes:
Support the work of the company and project teams in the provision of specialised IVD clinical consultancy to client companies, ensuring expectations are exceeded.
Ongoing project budget management and tracking.
Research and prepare clinical elements of a range of regulatory submission documents on behalf of client companies.
Prepare clinical operations Quality Management System audit reports and gap analyses on behalf of client companies.
Contribute to the preparation and/or delivery of educational and marketing activities as required.
Qualifications/ Attainments
Minimum 3 years IVD medical device experience in a similar role or equivalent.
Demonstrable awareness of ISO 20916 and its implementation to achieve and maintain IVD GCP compliance.
Demonstrable awareness of the requirements of clinical performance studies in accordance with EU IVDR and US regulations.
Experience in generating and reviewing documents relevant to clinical studies, such as Clinical Protocols and Monitoring Plans.
Confidence in managing stakeholder expectations on project delivery and budget; experience in organising and chairing client meetings.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Project Management, Information Technology, and Science
Industries
Biotechnology Research
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