Why join us?
CMR is one of the UK’s most exciting companies to be joining right now. The scale of our ambition to build a world-class medical devices company in Cambridge is matched only by the breathtaking innovation that underpins our next generation of surgical robot. We’re an award-winning company that plans to significantly disrupt the way surgery is performed for the benefit of millions of patients all around the world.
Our values are ambitious, humble, people focused and fair and responsible. If you share these values, our passion for improving lives, and have the skills to make a real difference to the way minimal access surgery is developed and delivered, then it’s a great time to join us.
- Contribute to the development and delivery of appropriate evidence generation and dissemination plans for pre-clinical and clinical studies to support CMR development pipeline, with collaborative relationships with all relevant cross-functional partners (Engineering, Sales & Marketing, Quality & Regulatory Affairs)
- Co-ordinate, develop, and run laboratory-based studies: protocol, data capture through to report close-out
- Contribute to the delivery of the pre-clinical and clinical studies, on time, within budget and in compliance with regulations and SOPs
- Develop and draft clinical trial protocols, informed consents, investigator brochures, and other study materials
- Plan for study budgets, develop of Investigator agreements and site contracts within fair market value (FMV), vendor agreements, payments, and financial disclosures
- Develop strong collaborative relationships with the study teams, including Investigators, research nurses, CROs, consultants, etc
- Draft study reports for assigned studies to include any annual reports for IRB / ECs as needed, study close out reports as well as clinical sections for regulatory submissions, such as CE, 510(k), and other regulatory submissions
- Involved with critically assessing the literature and drafting Clinical Evaluation Reports (CERs)
- Support clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy
- Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, study reports, and use of data/evidence for market access and reimbursement
We’re a high growth company and as such roles change and evolve. We’d expect you to be willing to turn your hand to anything within the Clinical remit that helps the team deliver its objectives.
A natural communicator hopefully goes without saying, but in addition we’d like you to have:
- Good understanding of research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations
- Ability to provide scientific research input across development and life-cycle studies
- Leadership requirement – ability to influence, shape and lead without direct reporting authority
- Minimum 2 years’ experience related scientific/technical/clinical research authority
- Ideally a PhD
- A genuine desire to help and support team members so that we can all achieve our best
We offer a competitive salary and a great benefits package (including non-contributory pension scheme, cycle-to-work scheme, life assurance, and our infamous monthly BBQs). On top of that, you’ll be joining a company with a fabulous culture of ambition, creativity and teamwork, and where fun is just as valued as our commitment to make surgery better for millions of people.