Clinical Project Manager

Do you have experience of organising and managing clinical investigations? Have you at least 3 years' experience of liaising with Clinical Research Organisations and Clinical Trials Units?
We have an exciting opportunity for an experienced Clinical Project Manager to assist us in setting up and overseeing clinical trials for our range of orthopaedic medical devices. This is a part-time role (0.6 F.T.E - 22.5 hours per week) based at our offices in Yeadon, Leeds.
Responsibilities
Organise and monitor clinical investigations, delegating to CROs and CTUs as required.
Co-ordinate studies with host centres and surgeons and ensure contracted deliverables are on time and to required quality.
Co-ordinate CRA activities for clinical investigations in line with regulations and GCP.
Estimate forecasted expenditure for clinical investigations.
Write clinical investigation protocols, clinical investigation reports, case report forms, investigator brochures and other CT documentation.
Manage ethical approval processes and regulatory authority applications/approvals.
In conjunction with the CRA, identify and assess the suitability of investigators and facilities to use as the clinical trial site.
Be responsible for the ethical approval process and regulatory authority applications.
Line manage and train and support the CRA and Assistant Clinical Project Manager.
Qualifications
At least three years' previous experience of undertaking a similar role with track record of successful execution of clinical trials.
Working knowledge of EU directives/UK regulations/ISO 14155.
Project or programme management qualifications or training.
Preferably previous experience of working with class medical devices.
We offer a competitive salary, which will be over £45k pro rata for an experienced candidate with more than 3 years' clinical trials experience. We offer a range of generous benefits including flexi-time, 26 days' holiday plus bank holidays (increasing with service), generous non-contributory pension, cash plan scheme, subsidised lunches, health and wellbeing initiatives, company events, free parking, full training and development opportunities plus option of private health insurance, gym membership, and option to choose additional holiday allowance on successful completion of probationary period.
Please apply with CV and cover letter to #####.
NO AGENCIES PLEASE.
P LEASE DO NOT APPLY UNLESS YOU HAVE A PERMANENT RIGHT TO WORK IN THE UK AS WE WILL NOT BE OFFERING SPONSORSHIP FOR THIS ROLE.