Clinical Operations Study Country Lead - all genders
Bring your passion for AI and data-driven thinking to clinical research that makes a real difference. If you're excited about using data to drive smarter decisions and improve patient lives, we want to meet you!
About the job
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
As Clinical Operations Study Country Lead (COSCL) you are the country level operational lead in clinical studies. You own, and are accountable for, the strategic planning, management and performance of your assigned clinical trials, for Germany, Switzerland, Austria - from country allocation until study closure at the Clinical Study Unit (CSU) level including study country timelines, study country budget, and study conduct in accordance with Sanofi Standard Operating Procedures (SOPs) and/or Quality Documents (QD)s and ICH/GCP and regulatory guidelines & directives.
As Clinical Operations Study Country Lead, you are the strategic hub at country level- connecting internal and external stakeholders to accelerate trial execution. You'll collaborate with:
- Globally:COSL, Data Management, Vendor Management, Study Medical Manager, Clinical Supply Chain Study Manager, Patient Recruitment & Retention Lead, and other Core Study Team members
- Locally:Clinical Research Associates, Clinical Project Assistants, Medical Advisors, Site Engagement Leads, Start-Up Strategy Managers, Medical Science Liaisons, and more
You represent the CSU in Core Study Team meetings, reporting to the CSU Team Lead while partnering closely with the COSL on study matters. You own full accountability for delivering the study as planned at CSU level - consulting or escalating to COSL when operational issues impact cost, speed, or quality.
Your main responsibilities will be:
- Set Up Local Study Strategy: Develop and initiate recruitment and retention strategies, identify successful site mapping, and set up site engagement plans. Organize local kick-off meetings and lead set-up activities to ensure progress.
- Manage Study Execution: Own local study performance, ensure compliance with timelines, drive performance with risk assessment, manage site engagement, and support site staff. Represent CSU in Core Study Team meetings and escalate issues as needed.
- Optimize Study Budget: Collaborate on budget preparation, manage financial resources, and address budget-related issues promptly.
- Facilitate Communication: Act as the main link to the local monitoring team, collaborate with Vendor Functional Line Managers, plan and participate in engagement activities, coordinate local team meetings, and establish collaboration with Medical Affairs.
- Ensure Quality and Compliance: Maintain data quality, patient safety, and compliance with study metrics. Ensure CRA training, collaborate on audit activities, and ensure system readiness.
AI expertise and data-driven thinking are essential - this role goes beyond traditional project management!
About you
Education and professional experience/knowledge:
- University degree in medicine, pharmacy, biology, biochemistry or related natural science
- Experience in clinical research is mandatory, preferably in combination with experience in project management and certain time as field monitor or site-coordinator.
- Solid knowledge of clinical development process and relevant therapeutic/disease area(s); GCP certificate
Soft skills:
- Strong skills in project management
- Data analytic skills and use of digital tools, platforms and systems
- Problem-solving and risk-management skills in a clinical study environment
- Change management skills
- Interpersonal skills with ability to create and foster trustful relationships with several internal and and external stakeholders
- Willingness to travel ~ 10-20% (in-country)
Languages: Fluent in German and English
Why choose us?
- 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.
- Benefit from a well-thought-out benefits package that rewards your contribution and commitment.
- We take care of you and your family with a wide range of health and social such as high-quality healthcare, numerous prevention programs and coverage for long-term illness. Our 14-week paid family leave for both parents is outstanding as well as a wide range of childcare benefits.
- Start your career at an attractive location in the center of Germany and experience our modern working environment and benefit from hybrid, flexible working time models.
#Li-onsite
Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.
The salary range for this position is :€79.104,00 - €105.472
Die endgültige Vergütung wird auf Grundlage nachgewiesener Erfahrung, Fähigkeiten, Standort und weiterer relevanter Faktoren bestimmt. Mitarbeitende können berechtigt sein, an den Mitarbeitenden Leistungsprogrammen des Unternehmens teilzunehmen.
