• Job title: CSU Clinical Trial Application (CTA) coordinator support (CTA-CS)

• Location: Budapest, Hungary

• Job type: Permanent, full-time

• Hybrid working with 60% office, 40% HO
  

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.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Join our team as a Clinical Trial Application Coordination Support (CTA-CS) and you’ll execute Clinical Trial Application related activities in support of the CTA processes (end to end process) of company Clinical Trials (CT). You will work in collaboration with global GRA CTA and EU Start Up Strategy Leader (SSL) teams. You will be a key member of a highly productive team.

Main responsibilities:

• Follow up/monitoring of CTA operational planning activities.

• Manage activities related to documentation: 

• Check CTA package completeness according to planning including version control, review and approval,

• Prepare necessary administrative Clinical trial application documents.

• File/ensure the filing of documents in the eTMF system

• Manage activities specifically related to the Clinical trials under the EU Regulation and its operational processes in the Clinical Trial Information System (CTIS) 

• Daily monitor any new activities (CTA status, Request for Information (RFI) status)

• Manage activities related to tools /Sanofi Regulatory document and registration tracking tools (Vault Regulatory Information Management (RIM))

• Creation of CTA related data objects, update data fields appropriately and required by internal SOPs and policies (#BeDataReady).

• Create and track review workflow

• Contribute to data QC, and appropriate data remediation

• Follow-up of submission and approval of CTA package with affiliates / partners

• Run KPI reports, collating data and reporting as per oversight and governance process. 

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 with a sharp attention to detail and the ability to handle multiple tasks simultaneously. Established ability to problem solve user issues.  Demonstrated critical thinking.

• Collaborative team player with orientation towards building and maintaining effective relationships, strong culture awareness.

• Ability to work under pressure, adaptability to change, solve problems and willingness to learn to drive to meet short deadlines and shifting priorities.

• Ability to communicate effectively, verbally and written, across varying functions and levels of management.

• Demonstrated continuous improvement mindset.

• Dedicated and persuasive “can-do” attitude and entrepreneurial spirit. 

Technical skills: 

• Knowledge and operational expertise in clinical trials regulation, Clinical Development Process, regulatory, ethical, and legal framework pertaining to study start-up is preferred.

• Working knowledge in Microsoft Office and Windows (Outlook, Word, Excel, PowerPoint), web skills a plus.

• Understanding of the relationship between systems and electronic databases.  

Education: 

• Bachelor’s degree or equivalent in regulatory affairs, the Sciences, or related areas of clinical study, and relevant experience (Science Degree or Life Sciences Degree).

Language(s):

• Strong English skills (verbal and written), ability to exchange fluently in a global environment.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment

• Work from an "Office of the Year 2023" award winner with flexible home office policy

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave

• 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

• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

PursueProgress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover Extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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.

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