Site Start Up EUCTR II
Primary Location: India, Hyderabad Job ID R0000042701 Category Clinical Trials
About this Role
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 new 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
We are seeking a Site Startup EUCTR II Specialist to join our team in a ON-SITE capacity. As a Site Startup EUCTR II Specialist, you will support the planning and execution of complex European Union Clinical Trials Register (EUCTR) submissions for large-scale Phase II and III clinical trials across multiple countries and sites. This position plays a key role in regulatory compliance, clinical trial application management, and ensuring seamless study startup across Member States. You'll collaborate with Clinical Trial Management, Regulatory Affairs, and Clinical Transparency teams to execute strategic study milestones and maintain regulatory alignment. Responsibilities include managing CTIS database submissions, coordinating multi-country regulatory documentation, and overseeing study startup activities from planning through enrollment initiation. With diverse teams and continuous learning opportunities, this role offers the chance to expand your expertise in European regulatory processes and influence the successful launch of critical clinical research programs.
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, institutions, and investigators throughout the study lifecycle
- Identify and capture key study-level and Member State-level milestones (Study Start, Enrollment Start/Completion, holds, restarts, cancellations) within the CTIS database and ensure all trial-related documents are archived in compliance with regulatory requirements.
Required Qualifications
- Bachelor's degree with 3-4 years of relevant experience in CTIS database, European Clinical Trials Regulation (EU-CTR), study startup, or clinical trial operations.
- Strong knowledge of ICH-GCP, EU/EMA and IVDR regulatory guidelines
- Tools experience with EUCTR, CTIS, CTMS, eTMF, and Site Startup activities.
- Experience with European regulatory processes and multi-country clinical trial submissions.
If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!
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