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Clinical Development Associate Manager Nr ref.: /JOBS.pl Job Background The Source department of Chiltern acts in a similar way to that of a staffing solutions provider. My client is a leading Pharma company; they are looking for a Clinical Development Associate Manager to join their team in Hungary (flexible location), 10 month contract initially (employed by Chiltern or freelance). Job Primary Functions Lead and coordinate activities that ensure quality, consistency, and integration of study data and progress operational deliverables to time cost and quality objectives from Study Specifications (SS) through study close-out activities and Clinical Study Report (CSR). Work with and lead cross-functionality, with internal and external partners, on global studies across different phases of drug development and different therapy areas. • Coordinate operational aspects of COMPANY and Investigator Sponsored studies from SS/Proposal through CSR/Publication. • Lead and/or participate in activities that ensure quality, consistency and integration of study data to agreed time, cost and quality objectives • Interface with Data Management Center representatives/Data Management Department, to facilitate the delivery of study data • Establish and maintain interactions with key stakeholders including the facilitation of communications with MCs, Strategic Partners, Academic clinics and investigational study sites, as appropriate, and external service providers (Third Party Vendors) to identify and resolve operational feasibility issues, facilitate study start-up activities, and ensure Operations deliverables to time, budget and quality objectives • Implement globally agreed Operations and Clinical Development strategies including processes and use of technical systems related to Operations • Contribute to protocol development and the development of other Operations documents as appropriate as well as any updates/amendments to those documents • Provide input and review data management deliverables (e.g. eCRF specification, Data Validation Specification, Data Management Plan) • Contribute to review of new/amended/unique project Clinical Information Standards (CIS) Standards Repository Components • Lead the preparation of study documents as delegated by Clinical Development Manager ( e.g. Informed Consent Form, Clinical Study Agreement, Patient Participation Card etc) A full job description is available. Requirements; • Previous international experience is required. • Therapy area - preferably respiratory, but the experience in country contact is more important. • Experience in a similar role. To apply please send a copy of your CV to , . Please note, if you skills/experience do not match the requirements for the role you may not get a response. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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