Site Start Up EUCTR II Specialist Post at PAREXEL

PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.

Post : Site Start Up EUCTR II

Job Description
About the Role
We are seeking a Site Start Up EUCTR II Specialist to join our team in a Hybrid capacity. As a Site Start Up EUCTR II Specialist, you will support the planning and submission of European Union Clinical Trials Regulation (EUCTR) Part II applications for complex, multi-country clinical trials. This position plays a key role in regulatory compliance, clinical trial transparency, and ensuring seamless coordination across multiple stakeholders. You'll collaborate with Clinical Trial Management, Regulatory Affairs, and Clinical Trial Transparency teams to execute submissions that meet EMA requirements via the Clinical Trial Information System (CTIS). Responsibilities include managing country allocations, capturing institutional and investigator information, coordinating document submissions, and monitoring trial milestones, with opportunities to deepen your expertise in regulatory affairs and clinical trial operations.
You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through advancing complex clinical trials across Europe. With diverse teams and continuous learning opportunities, the Site Start Up EUCTR II Specialist can explore career paths and expand skills across clinical research and regulatory operations.

Key Responsibilities
• Collaborate with Clinical Trial Management functional representatives to determine key study milestones and country allocation strategies
• Engage with Regulatory Affairs functional representatives to plan the Part II Clinical Trial Application (CTA) for EU countries
• Identify participating Member States and countries within the CTIS database and capture comprehensive study information
• Collect and upload applicable documents at the Member State and site level into the CTIS database for CTA submissions
• Coordinate with Clinical Transparency regarding document redactions required for CTA submissions
• Monitor and report on Part II activity progress to ensure alignment with overall trial timelines and objectives
• Ensure Part II CTA submissions comply with national regulatory requirements in each Member State
• Triage and manage Requests for Information (RFI) from regulatory authorities, coordinating responses with relevant stakeholders
• Collect required documents for IVDR (In Vitro Diagnostic Regulation) ethics submissions and ensure compliance with country requirements
• Maintain comprehensive trial documentation archives in compliance with regulatory requirements and company policies
• Identify and capture key study milestones including Study Start, Study Completion, Enrollment Start, Enrollment Completion, and hold/restart/cancel dates within CTIS

Candidate Profile
• Bachelor's degree with 3-5 years of relevant experience in clinical drug development, including study start-up activities
• Strong expertise in ICH-GCP, EUCTR, and IVDR regulatory guidelines
• Experience with trial management systems (CTMS) and electronic Trial Master File (eTMF) systems
• Experience with the Clinical Trial Information System (CTIS) or similar EU regulatory databases
• Experience with IVDR (In Vitro Diagnostic Regulation) submission processes
• Strong interpersonal and leadership skills with the ability to build productive cross-functional collaborations
• Proactive, self-disciplined approach with strong ability to meet deadlines and prioritize effectively
• Project management experience and proficiency with trial management systems, regulatory databases, and MS Office applications (Project, PowerPoint, Word, Excel)
• A regulatory mindset with strong attention to detail and commitment to compliance

Additional Information
Experience : 3-5 years
Qualification : Bachelor's degree
Location : India, Bengaluru
Industry Type : Clinical Trials
End Date : 20th September 2026