Clinical Study Manager - Oxford
Russell Oakley is recruiting for a Clinical Study Manager to join a very well funded new biotechnology company in Oxford, initially to oversee a large Phase IIb study. Our client is open to hiring the right person on a permanent or contract basis and home working will be possible for two days per week.Responsibilities:As a Clinical Study Manager you will manage a large scale Phase IIb study taking place in the UK late this year. As the company is still small in numbers you will need to happy working in a fast-paced environment and turn your hand to a very wide variety of functions.Key duties will include:- Management of all aspects of allocated studies in accordance with internal SOPs, ICH GCP and all applicable laws and regulations- Selection and oversight of CROs, third party vendors and contract staff- Periodic co-monitoring with contract CRAs and CROs to ensure high quality monitoring and site management- Management of clinical trials supplies in conjunction with third party storage and distribution specialists- Development and maintenance of strong relationships with sites and KOLsQualifications:As Clinical Study Manager you will require the following:- A relevant life science degree- Industrially based, early phase clinical project management experience- Experience of the management of third party vendors- An in-depth knowledge of the entire clinical trial process, from first in man through to regulatory filing for marketing- An excellent knowledge of GCP requirements and current clinical trial legislationPlease note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL41182 in all correspondence.