Site Start Up EUCTR II

Job description

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. 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 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 You'll thrive in this role if you bring: 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 Required Qualifications 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