CSU Clinical Trial Application (CTA) coordinator support (CTA-CS)
- Location: Budapest
- Flexible Working: Hybrid - 60% remote working and 40% office
- Job type: Permanent, Full-time
About the job
Clinical trials application is a key driver to deliver medicines to patients. As a member of the clinical team in charge of Clinical Trial Applications (CTA), the CSU Clinical Trial Application Coordinator Support (CTA-CS) will drive the day-to-day execution of the preparation of CTA (initial CTA, maintenance, and closure activities).
The focus of the team is to provide support on the CTA related activities in the scope of the EU Clinical Trial Regulation. You’ll operationally manage the activities linked with the Clinical Trial Information System (CTIS), which is the EMA portal for any kind of CTA submission in Europe. You’ll work closely work with the Global Regulatory Affairs Clinical Trial Application (CTA) coordinator support (CTA-CS) as well as Start Up Strategy Managers (SUSM) and Global Regulatory Affairs.
The CTA coordinator support will be a key member of a highly productive team, a collaborative team player, and driven by problem solving and ways of working improvement spirit, to achieve final Sanofi’s goal to conduct Clinical studies to bring new innovative medicines to patients having impact on people’s health and wellbeing.
- Manage activities specifically related to the Clinical trials under the European Regulation and its operational processes in the Clinical Trial Information System (CTIS)
- Daily monitor any new activities (CTA status, Request for Information (RFI) status, any other notice and alert)
- Follow up/monitoring of CTA operational planning activities
- Manage activities related to CTA documentation in close collaboration with the Clinical trial team, and the Regulatory team (coordinate, follow, check availability of component and completeness of CTA dossier and ensure availability of documents for Initial Clinical Trial Applications (CTA) preparation, CTA amendments and related activities)
- Prepare appropriate CTA documents in the Sanofi repository systems
- Monitor Key Performance Indicators by running reports, collating data and report as per oversight and governance process
- Prepare necessary administrative Clinical trial application documents
- Contribute to data QC, and appropriate data remediation
- Knowledge and operational expertise in clinical trials regulation or regulatory affairs is preferred
- Awareness or experience with Artificial Intelligence is desirable, however not essential
- Proactive and ability to embrace new activities
- Willingness to learn and to work with multifunctional and multicultural teams
- Ability to communicate effectively and efficiently with a dedicated and persuasive “can-do” attitude and entrepreneurial spirit
- Collaborative team player with orientation towards building and maintaining effective relationships, strong culture awareness
- Ability to operate with agility in a dynamic global environment and propose solutions and proactivity solve problems
- Ability to maintain discretion and confidentiality about sensitive data
- Strive to meet short deadlines and shifting priorities with demonstrated continuous improvement mindset
- Working knowledge in Microsoft Office and Windows (Outlook, Word, Excel, PowerPoint), web skills a plus
- Understanding of the relationship between systems and electronic databases
- Bachelor’s degree or equivalent in Regulatory Affairs, or The Sciences, Pharmacy or related areas in Clinical Study, and relevant experience (Science Degree or Life Sciences Degree)
- Strong command of the English language, ability to communicate in English (verbally and written) effectively and efficiently across varying functions and levels of management
When joining our team, you will experience:
- An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
- An attractive, market-oriented salary and cafeteria benefits
- Flexible home office policy, with a possibility to work up to 60% of time from home / where you can easily schedule your office days
- Work from an "Office of the Year 2020" finalist office
- Collective life and accident insurance
- Yearly medical check-up
- An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks
- Your own career path within Sanofi. Your professional and personal development will be supported purposefully
- Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)
Pursue progress. Discover extraordinary.
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.