Clinical Project Manager, Translational Biomarkers
Job Title: Clinical Project Manager, Translational Biomarkers
Salary: £ DOE (Junior and Senior candidates considered)
Job Purpose
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 Senior 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.
Working at ARC
At ARC Regulatory, our experienced team is passionate about supporting the advancement of high-quality biomarker testing in precision medicine research. Our work on +40 precision medicine programmes across oncology, autoimmune and cardiac therapy biomarkers, has helped deliver robust clinical data to expedite successful regulatory submissions and global market launches for pharma, laboratory and IVD clients, big and small.
ARC Regulatory continues to create a reputation as a "Great Place to Work". Our commitment centres around employee wellbeing. We enjoy a clearly defined company culture that puts team members, clients and patients, whose lives we seek to improve, at the centre of our day. ARC’s investment in career development means there is a career path available and each employee strengthens his/her knowledge of the complex regulatory environment for IVD and CDx medical devices.
We are an equal opportunity employer; applications are welcome from all and appointment will be made based on merit.