About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose. Moving with urgency to address patient needs and accelerate the delivery of current therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart(R).

About the Role

Key Responsibilities
- Collaborate with Clinical Trial Management and Regulatory Affairs teams to determine key study milestones, country allocation strategies, and coordinate Part II Clinical Trial Application (CTA) planning for EU countries
- Identify participating Member States, institutions,



and Primary Investigators for each country where the clinical trial will be conducted and capture comprehensive contact information within the CTIS database
- Collect, organize, and upload applicable country and site-level documents for Clinical Trial Application submissions into the CTIS database while coordinating with Clinical Transparency on necessary redactions
- Ensure all Part II CTA submissions comply with national regulatory requirements in each Member State and manage Requests for Information (RFI) by triaging questions and coordinating stakeholder responses
- Collect required documents for IVDR (In Vitro Diagnostic Regulation) ethics submissions and verify compliance with country-specific regulatory requirements
- Monitor and report on Part II submission progress to ensure alignment with overall trial timelines and objectives; maintain and manage the list of participating Member States,

📌 Site Start Up Euctr Ii (Hyderabad)
🏢 Parexel
📍 Hyderabad