affiliate: Innovex Clinical Location: Berkshire compose: 898969 Closing go out: 28 Oct 07 Type: beat Time Salary: 20000 - 30000 Benefits:Excellent benefits scheme
Job Summary: Experience of Good Clinical Practice clinical trial methodology terminology and procedures. Fluency both spoken and written in the French language. Professional come to all aspects of the job,Pleasant tactful and co-operative manner in face-to face meeting Excellent organisational skills. Requirements: We are recruiting for a new opportunity for a leading French investigate based organisation specialising in ethical pharmaceuticals. Employing over 450 populate in the UK they undergo an annual turnover of close to &hit;100 million showing a growth of 39% from 2004. It currently ranks within the top 15 largest pharmaceutical companies in the UK. Imminent new product launches ordain see it rise further up the rankings. You ordain be responsible :- &bear on; To ensure the implementation of Good Clinical learn and adherence to SOPs in the I. C. T. R in accordance with continue Office Quality Assurance policy and provide knowledgeable assistance in the continuing development of high quality of trials by positive reinforcement and furnish of advice and guidance to all cater involved. &bear on; To provide training advice and give in Quality Assurance related matters to all internal and external parties involved in I. C. T. R clinical studies i e. I. C. T. R cater (Project Leaders. Clinical Study Monitors. Data Managers and Secretaries) external clinical trial cater (delocalised monitors. CRO staff) investigators and associated site personnel. • To ensure the local quality control of clinical trial documents prepared by the I. C. T. R such as chew over protocols case report forms and patient information leaflets in compliance with SOPs. • To contribute to meetings with investigators at the request of communicate Leaders on all SOP and GCP-related issues. • To intend and/or conduct audits of designated study centres and to create detailed reports with recommendations for submission to the Therapeutic Research Direction. • To arrange and perform system audits on local I. C. T. R procedures to ensure beat compliance with SOPs and implementation of local compliance systems. &bear on; To be informed of any changes to international and national • regulations/guidelines relating to GCP and to declare any appropriate. &bear on; To act as a representative of the I. C. T. R. Quality Assurance in the interface with the Clinical Quality Assurance Division in France ensuring effective communication between the I. C. T. R and this Division for all matters relating to GCP and SOPs. • To act as and when appropriate in the “SOPs Review assort” with believe to the writing reviewing updating and translation of general SOPs. &bear on; To be responsible for ensuring that local requirements are implemented in local SOPs wherever allot and to co-ordinate the writing reviewing updating and validation of all local SOPs. • To apply and observe the production of any local documentation necessary to verify that systems developed used and validated in compliance with regulatory requirements. &bear on; To act as a representative of the I. C. T. R. Quality Assurance in the interface with the SETHI user representative in the UK and the SETHI Department in France ensuring effective communication between the I. C. T. R and this Department for all matters relating to SETHI Quality Assurance. &bear on; To be the Quality Assurance policy of the Company at meetings both in the UK and abroad. • To intend co-ordinate and review the working priorities of the Quality Assurance Officer ensuring that all tasks allocated are brought to effective completion within agreed deadlines. &bear on; To intend and apply the sign and on-going technical training of the Quality Assurance Officer. • To conduct the annual staff appraisal of both the shared secretary and the Quality Assurance Officer. The successful candidate needs to posses the follwing skills and attributes- undergo of Good Clinical learn clinical trial methodology terminology and procedures. Fluency both spoken and written in the French language. Professional approach to all aspects of the job,Pleasant tactful and co-operative manner in face-to approach meeting Excellent organisational skills. Clean British Driving Licence.
continue Office Innovex UK LtdRingside79 High StreetBracknellBerksRG12 1DZ SL7 1TB England
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