Senior Clinical Project Manager (Ivd/Cdx)

At ARC Regulatory, our experienced team is passionate about supporting the advancement of high-quality biomarker testing in precision medicine research. Our work on more than 40 precision medicine programmes across oncology, auto immune 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, with 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 career pathing available, and each employee strengthens his/her knowledge of the complex regulatory environment for IVD and CDx medical devices.

ARC Regulatory seeks applications from like-minded, culturally aligned and ethically strong clinical research professionals with 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:

• Leading 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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