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Regulatory and Site Services Specialist ( Lead) - CEE Nr ref.: /JOBS.pl ~~Job Summary: Due to our continuing success and expansion, we are looking to recruit Regulatory and Site services Specialists ( Leads) join our team in CEE Region. Chiltern is Europe's largest privately owned full service (Phase I-IV) Clinical Research Organization, with 4200 employees and offices throughout Europe, both Eastern and Western, North and South America and Asia. We have worked in virtually every therapeutic area for all the major pharmaceutical companies and very many of the smaller ones. Responsibilities: Department expert in regulatory and project start-up & maintenance activities for a particular country or region. Responsible for executing the majority of regulatory and start-up & maintenance activities on projects, within the project timelines and in line with the study start up portion of the budget. Requirements: • Minimum 2 - 4 years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job • Ability to maintain confidentiality of employee data and information during interactions with staff at all levels • Proficiency with MS Office programs • Demonstrated ability in all aspects of study start-up effectively, efficiently and with some supervision • Working knowledge of clinical research processes and terminology • Ability to communicate effectively in English, as well as the national languages of applicable countries • Understanding of the principles of ICH GCP and regulatory requirements • Working knowledge of CA and IRB/IEC and any other country specific authority/body submissions in assigned countries. • Experience of the clinical research process and terminology • Experience using a clinical trial management system, such as Insight or similar • BSc or BA degree in a biomedical or related life science, or nursing qualification • Experience as a mentor Additional Information: For a confidential discussion about this opportunity, please phone Magda Mirowska on + . To apply, please send your CV to For more information about Chiltern International, please visit our web site at Please note that if your experience does not mirror that of our requirements for this role you may not receive a response Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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