Clinical Operations Study Country Lead - all genders - #2124028

Role title: Clinical Operations Study Country Lead I - all genders

- Location: Berlin

- Languages required: German and English

About the job

Clinical Operations Study Country Lead I (COSCL) is the country level operational lead in clinical studies. He/she owns, and is accountable for, the strategic planning, management and performance of their assigned clinical trials, for GSA (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.

The COSCL I is the key strategic interface, at country level, with internal and external stakeholders to manage operational processes to accelerate trial conduct. Key interfaces for COSCL are:

• Globally: Clinical Operations Study Lead (COSL), Data Management, Vendor Management, Study Medical Manager, Clinical Supply Chain Study Manager, Patient Recruitment and Retention Lead and other Core Study Team members / transversal roles

• Locally: Clinical Research Associate (CRA), Clinical Project Assistant (CPA) Medical Advisor (MDA), Site Engagement Lead (SEL), Start-Up Strategy Manager (SUSM), Medical Science Liaisons (MSL) and other relevant roles.

COSCL I represents their CSU at the Core Study Team meetings.

COSCL I reports to CSU Team Lead, while working closely functionally with COSL for study topics. While the COSCL may consult COSL or escalate on operational issues that could affect study costs, speed or quality in the CSU, the COSCL is fully accountable to deliver the study as planned in their CSU level.

Main responsibilities:

• 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.

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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

• Problem-solving and risk-management skills in a clinical study environment

• Data analytic skills and use of digital tools, platforms and systems

• 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 English and German

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 / in the capital of Germany and experience our modern working environment and benefit from hybrid, flexible working time models.

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!

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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!

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