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Site Start up EUCTR II/ Initiation Clinical Research Associate II

India💼 Full-time🗓 2026-06-12 → 2026-07-28

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

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## 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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