Job Title: Clinical Trial Application Coordination Support (CTA-CS)
Location: Budapest, Hungary
Job Type: Permanent, Full-time (Hybrid working)
Posted on: Apr. 17, 2025
Closing on: Apr. 27, 2025
About the Job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
Sanofi is an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re offering countless opportunities to grow your career, explore new challenges, and connect with people globally.
Join our team as a Clinical Trial Application Coordination Support (CTA-CS) and execute activities related to Clinical Trial Applications (CTAs) for company clinical trials. You will work closely with global GRA CTA and EU Start-Up Strategy Leader teams and be a key part of a highly productive team.
Main Responsibilities:
Follow-Up/Monitoring: Monitor and follow up on CTA operational planning activities.
Documentation Management: Ensure CTA package completeness, including version control, review, approval, and the preparation of necessary administrative documents.
Filing: Ensure the filing of documents in the eTMF system.
Regulatory Compliance: Manage activities under the EU Clinical Trial Regulation and in the Clinical Trial Information System (CTIS).
Monitor Status: Track CTA status, Request for Information (RFI) status, and new activities.
Data Creation & Tracking: Create CTA-related data objects, update fields as required by SOPs, and manage review workflows.
Reporting: Run KPI reports, collate data, and report according to governance processes.
Collaboration: Follow up with affiliates/partners for CTA submission and approval.
About You:
Experience:
At least 3 years as a Clinical Research Project Manager or equivalent, ideally with at least 2 years of Clinical Trial Start-Up experience.
Soft Skills:
Excellent verbal, written, organizational, and interpersonal skills.
Ability to handle multiple tasks simultaneously with sharp attention to detail.
Collaborative team player with strong relationship-building abilities.
Ability to work under pressure and adapt to changing priorities.
Critical thinking, problem-solving, and continuous improvement mindset.
Technical Skills:
Knowledge of clinical trials regulation and study start-up processes.
Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint) and web skills.
Understanding of the relationship between systems and electronic databases.
Education:
Bachelor’s degree or equivalent in regulatory affairs, sciences, or related areas.
Languages:
Strong English communication skills (verbal and written) for a global environment.
Why Choose Us?
Innovative Environment: Work alongside a supportive, future-focused team in a globally recognized workplace.
Work Flexibility: Hybrid working model with a flexible home office policy.
Comprehensive Rewards: Competitive benefits package, including healthcare, wellness programs, and gender-neutral parental leave.
Community & Culture: Join a great community with events like monthly board game nights, sport clubs, and well-being lectures.
Sanofi is committed to a diverse workforce and provides equal opportunities for all applicants.
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