EMEA Business Development & Account Management Topical Segment (f/m/d)

DuPont; Frankfurt; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen sucht einen Senior Clinical Project Manager, der klinische Studien mit medizinischen Geräten leitet. In dieser spannenden Rolle sind Sie für die Verwaltung internationaler Studien verantwortlich, arbeiten eng mit interdisziplinären Teams zusammen und stellen sicher, dass alle regulatorischen Anforderungen erfüllt werden. Sie profitieren von einer offenen Unternehmenskultur mit flachen Hierarchien und flexiblen Arbeitsmodellen, die die Vereinbarkeit von Beruf und Familie fördern. Diese Position bietet Ihnen die Möglichkeit, Ihre Fähigkeiten in einem dynamischen Umfeld weiterzuentwickeln und einen bedeutenden Einfluss auf innovative Projekte im Gesundheitswesen zu haben.

Leistungen

Flexible Arbeitszeiten

Unterstützungssysteme

Mitarbeiterentwicklung

Betriebliche Kinderbetreuung

Jährliche Urlaubstage

Qualifikationen

• Mindestens 4 Jahre Erfahrung in der Leitung komplexer klinischer Studien.
• Umfassende Kenntnisse in klinischer Forschung und relevanten Vorschriften.

Aufgaben

• Leitung und Überwachung klinischer Studien mit medizinischen Geräten.
• Kommunikation und Management von Beziehungen zu Stakeholdern.

Kenntnisse

Projektmanagement

Teamführung

Klinische Forschung

Flexibilität

Problemlösungsfähigkeiten

Ausbildung

Bachelor in Lebenswissenschaften oder medizinischer Gesundheitsversorgung

Tools

MS Project

IVRS

EDC-Systeme

Jobbeschreibung

Senior Clinical Project Manager Medical Devices (m / f / d)

Location: Merz Aesthetics GmbH | Hybrid

Employment Type: Full Time

Experience Level: With Professional Experience

Responsibilities:

• You manage and oversee local and international clinical trials with a focus on medical devices.
• You lead internal and clinical cross-functional sub-teams and oversee internal deliverables, budget, forecasts, and timelines.
• You contribute to the preparation and review of key documents, including clinical study protocols, reports, plans, and informed consent forms.
• You provide up-to-date study status reporting on internal information systems and trackers.
• You select and qualify clinical trial vendors, create and implement sponsor and vendor oversight plans, and measure key performance indicators.
• You communicate effectively and manage relationships, stakeholders as well as escalations.
• You ensure adherence to internal SOPs and relevant regulatory requirements as well as identify quality risks and implement mitigations.
• You support quality audits and manage CAPAs in collaboration with involved functions.
• You create an open and trust-building working environment as well as promote effective changes.
• You support the improvement of internal processes, including SOPs, WIs, and new IT/software initiatives as well as evaluate new operating methods.

Qualifications:

• You have a university degree (Bachelor) in life sciences or medical healthcare or other professional qualifications equivalent to a university degree.
• You have at least 4 years of experience in managing complex, international clinical trials with medical devices on pre and post-market level.
• You have +8 years of comprehensive experience in different medical indications, study designs, and phases of clinical development of medicinal products or medical devices.
• You possess significant knowledge in clinical research and the conduct of clinical trials, including relevant regulations (ICH-GCP, ISO 14155, MDR, FDA, EU-CTR, etc.) and submission of clinical trial applications.
• You have profound experience in leading interdisciplinary and international teams.
• You are a team player and have professional team leadership skills.
• You have the ability to develop tools and processes that increase project efficiency.
• You have experience with IVRS and EDC systems.
• You demonstrate a high level of flexibility, self-motivation, commitment, and determination.
• You anticipate obstacles and proactively develop solutions to achieve project goals.
• You are structured, can work under pressure, build empathy, and motivate teams.
• You have comprehensive knowledge of project management methods and tools (e.g., MS Project).

What You Can Expect From Us:

Putting people first: You can expect to find an open work culture with flat hierarchies and short decision-making paths at Merz Aesthetics. You will collaborate with colleagues from all around the globe. If life takes an unexpected turn and you need help or advice, you can always rely on our different internal and external support systems.

Family and Work: Our employees should be able to reconcile their family and work commitments. That’s why you’ll find, for example, company daycare centers at our locations. In the EMEA region, we have been awarded the “Top Employer” and “Great Place to Work” certifications for our outstanding HR policies and work culture.

Work-Life Harmony: Our time is precious; our daily routines are individual. To help you reconcile work and leisure time with their conflicting demands, we have adopted contemporary flexible working time models. We offer you flex-working time and mobile working. Our employees also benefit from generous arrangements for annual leave.

Ongoing Training: Your personal and professional development is the key to success for us. To foster this, we conduct regular development discussions and facilitate a wide range of management and specialist training courses, soft skills courses, e-learning courses, language courses, and coaching sessions.

Find out more about our benefits at careers.merz-aesthetics.com.