Site Start up EUCTR II/ Initiation Clinical Research Associate II
Core
Planning and submitting complex EUCTR submissions for large Phase II and III trials across multiple countries and sites.
Role type
Site Start Up Clinical Research Associate
Builds
Regulatory submissions for clinical trials
Domain
Clinical drug development / Regulatory affairs
Deliverable
client delivery
Required skills
Vendor management, Trial management systems (CTMS, TMF), Project management, Cross-functional team interaction, ICH/GCP/EUCTR/IVDR regulatory knowledge, Study start-up experience
Preferred skills
Leadership, Data-driven planning, Strategic direction implementation
Technologies
CTMS, TMF, MS Project, PowerPoint, Word, Excel
Responsibilities
Plan and submit complex EUCTR submissions, Implement operational strategic direction for clinical studies, Manage study team collaborations, Manage vendors
Seniority
Mid-level, hands-on IC
Rewrite
## About the Role
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.
## Responsibilities
- Responsible for planning and submitting the complex EUCTR submission i.e. large phase II and III trials with multiple countries and sites.
## Requirements
- 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.
## Nice to Have
## Benefits
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