Clinical Operations Study Country Lead - all genders at Sanofi Aventis US LLC

Frankfurt, Hesse, Germany -

Full Time

Start Date

Immediate

Expiry Date

26 Jun, 26

Salary

0.0

Posted On

28 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Data Analytics, Risk Management, Change Management, Interpersonal Skills, Stakeholder Management, Clinical Research, GCP, AI, Data-Driven Thinking, Strategic Planning, Budget Management, Compliance, Vendor Management, Site Engagement

Industry

Pharmaceutical Manufacturing

Description

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 Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube

Responsibilities

The Clinical Operations Study Country Lead is the operational lead at the country level, accountable for the strategic planning, management, and performance of assigned clinical trials in Germany, Switzerland, and Austria from allocation to closure. This role involves owning study country timelines, budget, and conduct while acting as the strategic hub connecting internal and external stakeholders to accelerate trial execution.