Clinical Research Associate II - Site Start Up and EUCTR Submission

Site Start up EUCTR II/ Initiation Clinical Research Associate II When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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. Experience Level Mid Level