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Clinical Monitoring Oversight Manager / Monitoring Lead (f/m/d)

Full Time
Frankfurt am Main, Deutschland
Experienced Professional
March 14, 2024
Hybrid
Clinical Monitoring Oversight Manager / Monitoring Lead (f/m/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 36 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:
  • Oversee site and monitoring activities across our clinical studies to maintain quality standards, identify trends and evaluate compliance by reviewing a percentage of study documents, metrics, outputs as well as ensuring that related CAPAs are implemented 
  • Oversee site inspection readiness, TMF health, investigator and CRA trainings and support site and sponsor audits/inspections
  • Perform selected Co-Visits at investigational sites and attend investigator meetings, travel up to 50% can be required
  • Oversee vendor activities on a higher level as well as vendor qualification/selection including assessment of their monitoring processes & tools, KPI determination, metrics review and governance meetings
  • Develop/Maintain up to date monitoring SOPs, tools and templates including risk-based and centralized monitoring as well as a QTL database and tracking
  • Report regularly to Senior Management and liaise with The Clinical Operations Group including team trainings as needed
WHAT WE EXPECT FROM YOU:
  • >6 years’ experience in different medical indications, study designs and phases of clinical development of medicinal products or medical devices, wheareas >2 years’ experience as a Lead CRA, Clinical Trial Lead or equivalent and a previous career as CRA
  • Significant knowledge in clinical research and in the conduct of clinical trials including significant knowledge in relevant regulations (ICH GCP, EU CTR, MDR, FDA, etc.) and standard applications such as CTMS, IVRS and EDC system
  • Fluent business English, excellent keyboard skills and profound MS Office skills as well as basic statistical understanding is required
  • Significant verbal, written communication and presentation skills and experience with leading interdisciplinary and international teams
  • High flexibility, self-motivated and solution-oriented, used to work independent and with self-initiative
  • Ability to forward thinking and planning, prioritize multiple tasks, plan proactively
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 Employee Assistance Program.

  • 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. We have been awarded the “Family-Friendly Company” certificate from the Hertie Foundation for our commitment to family and work.

  • 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 flextime/trust-based 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 this end, we hold 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 here.

We are looking forward to your application!

You can find more information at https://merz-aesthetics.info/

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