Senior Project Manager/ Study Delivery Excellence Lead

Posted on Mar 15, 2019 by Synteract

Not Specified Belgium
Research & Development
12 Mar 2019
Annual Salary
Full-Time
Senior Project Manager/ Study Delivery Excellence Lead (m/f) - Brussels Office based Who We Are Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of "Bringing Clinical Trials to Life," we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare. Position Overview 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. Specific tasks would include: 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) If you're passionate about bringing clinical trials to life, we encourage you to apply today! Please apply online stating your earliest start date/notice period and your desired salary. If you have any questions regarding your application please contact . Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Candidates must possess current and valid authorization to work in the country to which they are applying.

Reference: 671078695

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