Country Approval Specialist Italy 12 month FTC-134693 Nr ref.: /JOBS.pl PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 16,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit a great opportunity exists for an experienced professional to join our team at the position of:Country Approval Associate in Milan on a 12 month FTCThe basic purpose of this position may include, but is not limited to, activities related to obtaining Investigational Product (IP) approval for an individual or group of sites across one or more clinical study including: Site management Informed consent form review and approval Regulatory document collection, review and transmittal approval Adherence to project timelines & expectations Objectives include the successful coordination of all regulatory and Ethics Committee (EC) tasks required for site IP approval in accordance with FDA Good Clinical Practices, ICH Guidelines and Global Standard Operating Procedures. Represents PPD in the global medical research community and develops collaborative relationships with investigative sites and client company personnel during the start-up of clinical trialsQualificationsEducation and Experience:Bachelors Degree in Life or Health Science, or Nursing DegreeMeets at least one of the following criteria:- 2 years experience in Study Start-up, or- 2 years of an equivalent experience with regulatory documents and knowledge of applicable FDA ICH/GCP guidelines/regulations in a pharmaceutical, clinical research, or clinical site setting (i.e. Study Coordinator, IRB Coordinator)Formal training in Medical TerminologyOr an equivalent combination of education and experience that provides the required knowledge, skills, and abilities to perform the job Knowledge, Skills and Abilities: Ability to review and/or negotiate all required essential regulatory documents for completeness and readiness as required for site IP Approval and ensure that ongoing awareness of IEC/IRB submission deadlines, meeting dates and procedures are communicated to start-up team members as appropriate Ability to negotiate with difficult investigators, research nurses and site staff to reach desired resolution Ability to identify activities along critical path toward individual site IP approval and completion of all site start-up activities for a study Ability to effectively analyze project specific data, systems and deliverables to ensure accuracy and completeness Ability to extract pertinent information from all study documents such as protocols, informed consents, contracts, etc Ability to review and approve draft or IRB approved informed consent form document (ICF) using the appropriate ICF checklists to document the review Knowledge and understanding of medical and clinical trials terminology Ability to work independently or with minimal supervision with multiple sites simultaneously and handle multiple tasks effectively while keeping up with rapid changes of priorities without loss of efficiency Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .
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