Clinical Program Manager
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An opportunity has opened for a Clinical Study Manager (Clinical Program Manager) to join a growing Medical Devices company based in the UK in a home-based position within the surgical devices space. With almost 3,000 employees globally, my client is an established Medical Devices company with multiple success sorties over the years making them pioneers in their space. You'll be joining the UK Clinical Operations team at an exciting time of growth, where you'll have the chance to develop there long term in the future due to their recent funding and outstanding product portfolio.
Right now, this is a small team in the UK with 10 people in Clinical Operations where you'll work closely with the US team on the day to day running of their global study portfolio so having this experience prior is a plus but not essential. Whilst running the global studies, you'll be working in a varied position as you'll be the face of the EU Clinical Operations business so having at least 2-4 years of Project/ Study Management is desired.
To manage and conduct a program of clinical studies and related clinical activities, to support product registrations, market access, claims and provide regulatory and commercial support. Delivery of clinical program in line with R&D, Regulatory and Commercial objectives.
Assistance and support in certification and regulatory submission of new products through the clinical evaluation.
Previous experience in the management and co-ordination of clinical trials is essential together with the appropriate academic and/or vocational qualifications.
- Manage post-market surveillance/post market clinical follow up activities for existing and new devices
- Responsible for development of Investigator Brochures, monitoring plans, clinical trial protocols, identification, and oversight of CRF development in line with regulations and relevant standards.
- Establish and maintain procedures to ensure adherence to trial protocols and administrative requirements.
- Creation and maintenance of all trial files, including the trial master file, and oversight of site files.
- Manage the overall efficient day-to-day management of the trials through third party clinical trial organisations. Monitor, track progress and obstacles throughout the duration of clinical trials.
- Management of the trial budget(s) and maintenance of the accounts.
- Provide clinical advice and guidance to the NPI and design change teams to ensure compliance with applicable regulations.
- Liaise with medical writers to help prepare and maintain clinical evaluation reports to meet the requirements of the EU Medical Device Regulation
- Within an environment of rapidly changing technologies, and the increased need to generate evidence on the performance of our products, the jobholder manages clinical studies and acts as a clinical research expert, working with USA and EU studies, as well as the broader team stakeholders.
- 2-4 years Clinical Project Management experience within a Medical Devices setting
- CRA background - ideal, but not essential
- EU Trial Management experience
- CRO/ vendor management background
- Budget management experience
- A 'can do' attitude where you can thrive in a dynamic environment
What's on offer?
A highly flexible basic salary + 10% bonus, 5% matched pension, 25 days holidays, Healthcare, Life Insurance etc.