Country Study Manager
Russell Oakley at CK Clinical is recruiting for a Country Study Manager to join a company in the pharmaceutical industry at their site based in Hertfordshire on a contract basis.
The main purpose of the role will be to Provide leadership to one or more study teams and provide local project planning and management to achieve successful study completion. The CCO CSM maintains full ownership of the CCO portion of a study and ensures the effective, efficient and compliant delivery of country/region operational aspects in accordance with the study development plan and ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements. The CCO CSM also ensures the development and maintenance of productive relationships with our customers.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience: University degree or equivalent in a medical/science-related field or nursing degree and/or 5 years proven experience in a Clinical Research/Development or related industry. Able to communicate clearly and accurately in both written and spoken English. Demonstrated ability to interact with different professional levels of the research community. Strong leadership skills developed through leading multi-functional matrix study teams through all stages of clinical studies. Proven clinical development experience on the operational aspects of conducting clinical studies which may include vendor/CRC management, leading/working as part of a development team, implementing clinical development plans and coordinating study level activities to deliver data for filing or publication purposes including interaction with local Business Units. Experience in project management including implementation of risk management plans and management of complex study budgets and resourcing plans. Experience influencing and negotiating at all levels to achieve team delivery. Excellent written and verbal communication skills demonstrated by an ability to present clear messages from complex information/data to all levels in the organisation. Demonstrated ability to prioritize and manage multiple tasks. Self-motivated and achievement driven. Excellent knowledge of ICH GCP and the EU Clinical Trials Directive and the legal and regulatory requirements for the conduct of Clinical Trials in the UK. Strong computer skills - experience using various computer applications including spreadsheets, email, word-processing software. International travel required.
For more information or to apply for this position, please contact Russell Oakley on 01246 457733 or email email@example.com . Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer who 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 CL35025 in all correspondence.