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.