Clinical Operations Study Country Lead (all genders)

卡湯晩; Berlin; Hybrid; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

Ein innovatives Unternehmen sucht einen Clinical Operations Study Country Lead, um klinische Studien in Deutschland zu leiten. In dieser Schlüsselrolle sind Sie verantwortlich für die strategische Planung, das Management und die Durchführung klinischer Studien, während Sie eng mit internen und externen Stakeholdern zusammenarbeiten. Sie werden die lokale Studienstrategie entwickeln, die Studienausführung optimieren und sicherstellen, dass alle Qualitäts- und Compliance-Anforderungen erfüllt werden. Wenn Sie eine Leidenschaft für klinische Forschung haben und in einem dynamischen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Leistungen

Umfassende Gesundheitsleistungen

Familienurlaub

Kinderbetreuungsleistungen

Moderne Arbeitsumgebung

Flexible Arbeitsoptionen

Qualifikationen

• Erfahrung in klinischer Forschung und Projektmanagement ist erforderlich.
• GCP-Zertifizierung und Kenntnisse in klinischer Entwicklung sind von Vorteil.

Aufgaben

• Entwicklung von Rekrutierungsstrategien und Verwaltung des Studienbudgets.
• Sicherstellung der Qualität und Einhaltung der Vorschriften während der Studienausführung.

Kenntnisse

Projektmanagement

Problemlösung

Risikomanagement

Datenanalyse

Interpersonelle Fähigkeiten

Ausbildung

Universitätsabschluss in Medizin oder verwandten Naturwissenschaften

Tools

Digitale Tools

Jobbeschreibung

Clinical Operations Study Country Lead (all genders)

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

About the job

Clinical Operations Study Country Lead I (COSCL) is the country-level operational lead in clinical studies. They own and are 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. This includes managing study country timelines, budgets, and study conduct in accordance with Sanofi SOPs, QDs, ICH/GCP, and regulatory guidelines.

The COSCL I serves as the key strategic interface at the country level with internal and external stakeholders to manage operational processes and accelerate trial conduct. Key interfaces include:

• 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 team members.
• 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 Core Study Team meetings and reports to the CSU Team Lead. They work closely with the COSL on study topics and are fully accountable for delivering the study as planned at the CSU level.

Main responsibilities:

1. Set Up Local Study Strategy: Develop recruitment and retention strategies, identify successful site mapping, and set up site engagement plans. Organize kick-off meetings and lead setup activities to ensure progress.
2. Manage Study Execution: Own local study performance, ensure timelines are met, assess risks, manage site engagement, and support site staff. Represent CSU in meetings and escalate issues as needed.
3. Optimize Study Budget: Collaborate on budget planning, manage financial resources, and address budget issues promptly.
4. Facilitate Communication: Act as the main link to the local monitoring team, collaborate with vendor managers, plan engagement activities, coordinate local meetings, and work with Medical Affairs.
5. Ensure Quality and Compliance: Maintain data quality and patient safety, ensure compliance with study metrics, provide CRA training, support audit activities, and ensure system readiness.

About you

Education and experience: University degree in medicine, pharmacy, biology, biochemistry, or related natural sciences. Experience in clinical research is mandatory, ideally combined with project management and field monitoring or site coordination experience. Strong knowledge of clinical development and relevant therapeutic areas; GCP certification. Skills in project management, problem-solving, risk management, data analysis, and digital tools. Interpersonal skills to foster stakeholder relationships. Willingness to travel ~10-20% within the country.

Languages: Fluent in English and German.

Why choose us?

Join a supportive, innovative team and bring science to life. Enjoy opportunities for growth, both locally and internationally. Benefit from comprehensive health and social benefits, including healthcare, family leave, and childcare benefits. Work in a modern, flexible environment in Berlin, with hybrid working options. Be part of a diverse team committed to making miracles happen, embracing change, and exploring new opportunities. We are committed to equal opportunity for all.

Sanofi is dedicated to supporting health challenges worldwide and is a global biopharmaceutical leader focused on human health.