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Site Start up EUCTR II/ Initiation Clinical Research Associate II

Primary Location: India, Hyderabad 求人ID R0000042680 Category Clinical Trials
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About this Role

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.
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