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Senior Clinical Project Manager (m/f/d)

Full Time
Eckenheimer Landstraße 100, 60318 Frankfurt am Main, Deutschland
Experienced Professional
July 11, 2024
Hybrid
Senior Clinical Project Manager (m/f/d)

Merz Aesthetics is an international company in the field of aesthetic medicine. Our broad product portfolio is synonymous with top quality in each of their categories and is highly regarded by healthcare professionals worldwide. As Merz Aesthetics, we are part of the Merz Group with our EMEA headquarters located in Frankfurt am Main, Germany. Our global head office is located in Raleigh, North Carolina, USA. Every day, more than 2,500 employees in 26 countries are committed to restoring and maintaining the skin's beauty. Would you like to become part of our success story? Then join Merz Aesthetics!

The following responsibilities are awaiting you:
  • You manage and oversee local and international clinical trials with investigational medicinal products and medical devices and support detailed planning of new clinical programs and strategies (budget, timelines, operational aspects and feasibility)

  • You represent Clinical Operations as a core team member on internal cross-functional project teams and lead internal and clinical subteams (e.g. lead meetings, oversee internal deliverables and timelines)

  • You are responsible for selecting and assisting with the qualification of clinical trial vendors, create sponsor and vendor oversight plans, implement oversight plans and measure key performance indicators by e.g. participating in key vendor oversight meetings, overseeing vendor proposals, contracts, change orders, invoices, and purchase orders 

  • You also manage study budgets in accordance with the existing finance processes (e.g. budget tracking tool, accruals, forecasts)

  • In order to ensure adherence to internal SOPs and relevant regulatory requirements, you identify quality risks and implement mitigations, provide up-to-date study status reporting on internal information systems and trackers and participate in investigational site visits and/or CRA co-visits, while supporting quality audits and managing CAPAs in collaboration with the involved functions

  • Your responsibility is also to contribute to the preparation of key documents (e.g. clinical study protocol, clinical study report, informed consent form) and review study specific plans  
           
  • Additionally, you promote effective changes, create an open and trust-building working environment and ensure and support the globalization of the organization 

  • You evaluate new operating methods, develop and improve internal processes (SOPs, WI, new IT/software initiatives etc.) and participate in cross-functional tasks forces or initiatives as requested          
What we expect from you:
  • University degree in life sciences or medical health care (Bachelor) or other professional qualifications equivalent to university degree

  • At least 4 years' experience in different medical indications, different study designs, different phases of clinical development of medicinal products or medical devices 

  • At least 4 years' experience in the management of complex, international clinical trials 

  • Comprehensive experience in clinical study processes, incl. submission of clinical trials applications and the leadership of interdisciplinary, international teams

  • Significant knowledge in clinical research and the conduct of clinical trials, including relevant regulations (ICH GCP, EU CTR, MDR, FDA, etc.)

  • Proven track record of professional team leadership skills and the ability to develop tools and processes that increase measure efficiencies projects

  • Comprehensive project management methods and tools (e.g. MS Project) and proficiency in Microsoft Office and experience with IVRS and EDC system, paired with general affinity for IT

  • Excellent verbal and written communication and presentation skills in English

  • High flexibility, self-motivation and solution-orientation, as well as high level of commitment and determination
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. And if life takes an unexpected turn and you need help or advice, then 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 day care 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 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 https://careers.merz-aesthetics.com.

We look forward to your application!

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