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Administracja biurowa » Pracownik biurowy

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Study Delivery Excellence Lead / Senior Project Manager Nr ref.: /JOBS.pl Study Delivery Excellence Lead / Senior Project Manager (m/f) Brussels SynteractHCR is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development, located in EU, RUS, US and South America. We are looking for a dedicated Senior Project Manager that has a focus on Risk Management and Compliance topics. Your tasks Support the Clinical Operations team with ICH/GCP expertise, regulations advice and act as a valuable member for clinical decision making that also influences operational efficiencies, effectiveness and business decisions. Support the implementation of the Internal Control Framework. A first mission will be the development of an ICH-GCP customized training for the clinical team and to train all functions and future trainers. Other responsibilities are providing guidance and hands-on advice in the day to day activities to teams in: Risk management oversight: facilitation of the clinical studies and the end-to-end clinical trial development process including performance management Risk-based management monitoring (Quality Control): deployment / coordination Act as a training partner: ensuring training operational excellence Audit & Inspection activities: support preparation, conduct, follow-up CAPA coordination and management following monitoring (business or independent) Coordination and support of issue / escalation management Contribute to the development, improvement & simplification of standards and processes. Ensure that standards and processes are implemented globally with a high level of compliance and quality Maintain ongoing communication with designated members from different departments to address risk management issues, to align corporate initiatives, to ensure end-to-end cross-functional approach, to work on trends, problems, issues, and other clinical monitoring opportunities in an efficient way. Qualifications University Degree in life science / healthcare required A minimum of 6-10 years of relevant experience in clinical development Investigation and negotiation skills, develop and implement new procedures when needed as well as predisposition to quality management, project management and process improvement. In depth knowledge of regulatory guidelines, ICH/GCP and Epidemiology guidelines. Ability to work well within a matrix environment Effective ability to prioritize tasks and deliver on deadlines, with high performance standards and a commitment to excellence. Excellent English language skills (verbal and written) To apply Have we sparked your interest? Then we are looking forward to receiving your application! Please apply through our homepage synteracthcr.com and state your earliest start date/notice period and your desired salary. If you have any questions regarding the position please contact Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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