Job Information
Sanofi Group Local Study Manager in Budapest, Hungary
Job title : Local Study Manager
Location: Budapest, Hungary
Hybrid
Full-time; Permanent
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. Join our Clinical Operations Team as Local Study Manager and you’ll be accountable for the strategic planning & management and performance of assigned clinical trials within feasibility process until study closure inclusive archiving at the CSU level including study timelines, study budget, and study conduct.
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?
Main responsibilities:
Early participation to address operational aspects in the study country strategy in partnership with relevant parties to ensure a smooth and fast path to the First Patient In:
identifies gaps and initiates risks assessment in processes, vendors services and resources
Lead Country Study Set up to ensure progress according to study timelines with strategic planning
Lead local study management at the country level from operational point of view starting with experience sharing during feasibility process, through end of the study according to global and local study plan:
Attends feasibility meeting to collaborate with SEM and MDA to identify most probably successful sites even for feasibility process
Initiates early exchange with Medical Affairs to identify important sites and/or new sites
Participate in the study MDA handover meeting following country allocation
Organize the Local Kick Off Meeting with respective local study team members
Prepare and lead Local Investigators Meeting; Participate in the regional/global Investigator Meeting.
Oversees Study Budget at country/cluster level and ensures optimization and appropriate management of the financial resources:
Promote effective communication between all parties involved in the study to align common goals and define effective strategies
Maintain Quality and Compliance through vendor oversight of all project deliverables according to project timelines and KPIs
About you
Experience :
3 years of experience in clinical research are mandatory, preferably in combination with experience in project management and certain time as field monitor or site coordinator
Knowledge of GCP/ICH phase I-IV clinical trials and observational studies
Trained for Compliance and Business Integrity
Soft and technical skills : Excellent Project Management skills,
Strong problem solving skills
Strong Data Analytics (& Digital) skills
Education : Bachelor’s degree or higher degree in Health or Natural Sciences or equivalent experience depending on the country.
Languages : Fluent in English
Willing to travel.
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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
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