Regulatory and Site Services, Lead Nr ref.: /JOBS.pl Chiltern is Europe's largest privately owned full service (Phase I-IV) Clinical Research Organization, with 4000 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. Due to our continuing success and expansion, we are looking to recruit Regulatory Project Lead to join our team in Spain or Italy - full time, permanent role. 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 of 5 + years' experience in a clinical research role with a pharmaceutical company and/or CRO, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job • In-depth experience with clinical trial study start-up activities and thorough knowledge of the applicable guidance and regulations • Ability to maintain confidentiality of employee data and information during interactions with staff at all levels • Proficiency with MS Office applications • Ability to communicate effectively in English • Understanding of the principles of project management, ICH-GCP, and regulatory requirements • Recent mentoring, training and line management experience in start-up or related area. • Experience in conducting feasibility pre & post-award as applicable. • Solid understanding of national CTA directives, regulations and guidelines in the countries of operation as applicable • Solid financial and business acumen • Prior experience supervising regulatory and / or clinical trials staff • Prior clinical trials project management, department management or specific leadership experience, including international studies. Additional Information: This is a full time permanent role, office or home based For a confidential discussion about this opportunity, please phone Courtney Stiven 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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