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?

• 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

• 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

• Excellent Project Management skills
• Strong problem solving skills
• Strong Data Analytics (& Digital) skills
• Knowledge of GCP/ICH phase I-IV clinical trials and observational studies
• Trained for Compliance and Business Integrity
• Willing to travel

• Bachelor's degree or higher degree in Health or Natural Sciences or equivalent experience depending on the country.

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
• 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.