Site Start up EUCTR II

Job description

Site Start Up EUCTR II • Responsible for planning and submitting the complex EUCTR submission i.e. large phase II and III trials with multiple countries and sites. Job Requirements: In addition to the core duties outlined, the following qualifications are required for the Site Start Up EUCTR II • Interpersonal & leadership skills • Ability to understand and implement the operational strategic direction and guidance for respective clinical studies • A data driven approach to planning, executing, and problem solving • Effective communication skills via verbal, written and presentation abilities • Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization • Ability to build productive study teams collaborations • Vendor management experience • Basic proficiency in trial management systems (CTMS, TMF) and MS applications including (but not limited to) Project, PowerPoint, Word, Excel • Experience in the clinical drug development process, including study start-up • Knowledge of ICH/GCP, EUCTR and IVDR regulatory guidelines • Basic project management skills, cross-functional team interaction and organizational skills • May require up to 25% travel • Bachelor’s degree and 3-4 years of relevant experience.