• Location: Budapest

• Hybrid working according to local policy

• Job type: Permanent, full-time

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 global Clinical Sciences and Operation (CSO)’s Start Up Strategy team as a Start Up Strategy Lead (SUSL) and you will oversee the Part II submission in the context of EU Clinical Trial Regulation (EU CTR). You will work in collaboration with the appropriate stakeholders (e.g. GSM, SUSM, GRA as well as with applicable countries and vendor) to ensure that submission in CTIS is completed in accordance with the plans and with respect to quality and timelines. 

Main responsibilities:

• Manage activities specifically related to the Clinical trials under the EU Regulation and its operational processes in the Clinical Trial Information System (CTIS). Oversee CTIS related activities performed by Study Start Up (SSU) Administrative team (CTA-CS)

• Align with CTA Manager in GRA and communicate the strategic Part II submission plan. With a risk management mindset, escalate risks and prepare appropriate preventative and mitigation plans

• Follow up/monitor CTA operational planning activities and on submission and approval of CTA package with affiliates / partners. Ensure distribution preparation and tracking submissions for all entities

• Daily monitor any new activities

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

• Manage activities related to documentation:  in close collaboration with the Clinical trial team, the Regulatory team (follow, check, and ensure availability of documents for Initial Clinical Trial Applications (CTA) preparation, CTA amendments, etc) , coordinate translation requests if needed and coordinate content owner review of materials for feedback and revision.  

• Communication: Be the Point of Contact (POC), for the EU CTR part II management: the SSL is responsible for the coordination of the collaboration between EU CSU SUSM at country level, study COSL and GRA team for any part II activity, monitoring and ensuring country readiness for the study submission allocated and CTIS entry

• Promptly escalate to the CSU SUSM any potential impact that may affect the country SIV timelines and delivery

• Performance and quality/continuous improvement:Review performance for every study and implement process improvement initiatives

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
• Knowledge in Clinical Development Process, and of development in recent technology and how to utilize to optimize outcomes, regulatory, ethical, and legal framework pertaining to study start-up
• Experience in the Pharmaceutical Business or related industry, broad scientific knowledge across different therapy areas is a plus

Soft skills:

• Stakeholder and Interpersonal & Relationship management;
• Good communicational skills, ability to work independently and within a team environment,
• Experience in working with cross-functional teams, emotional intelligence
• Problem-solving skills and risk management

Technical skills: Formal training or experience in Project Management; MS Office Suite 

Education: Bachelor’s degree or higher in Life Science or equivalent

Languages: Excellent knowledge of English language (spoken and written) 

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)

Pursue Progress. 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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