Clinical Project Manager (m/f/d)

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 1,600 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:

• You oversight and execute operative planning, preparation and conduct of clinical trials with investigational medicinal products and medical devices
• You coordinate internal and external operations tasks, team meetings and communicate the timelines with respective functions
• You lead internal and external teams and manage professional meetings
• You plan and control the timelines and the budget incl. payments of external provider
• You monitor the quality of deliverables according to SOPs and regulatory requirements and you identify quality risks and implement mitigations
• You internal report and present study status according to matrix structure and using project management information systems and databases
• You select, qualify and oversee external provider incl. budget, quality and timelines
• You train vendor personal about the study and expectations (SOPs, Protocols, trial processes etc.)
• You contribute to the preparation of study documents and you prepare operational documents or approve operational documents ions prepared by external provider
• You prepare and support audits and manage CAPAs in collaboration with involved functions
• You conduct feasibilities, select, train and monitor and co-monitor investigational trial sites
• You review data during study conduct and support oversight of the data process
• You provide input into internal processes (SOPs, WI, new IT/software initiatives etc.)
• You evaluate the impact of a new regulation on clinical project and internal processes
• You serves as a resource for others within the company for clinical trial management expertise
• You represent Clinical Project Management in cross functional teams or tasks forces as requested

WHAT WE EXPECT FROM YOU:

• You have an university degree in life sciences or medical health (Bachelor) or other professional qualifications equivalent to university degree
• You have experiences in different medical indications, different study designs, and different phase of clinical development of medicinal products or medical devices. (>4 years)
• You have significant experiences in the management clinical trials (> 2 years) in the APAC region (especially China) 
• You have significant experiences in clinical study processes and significant experiences in the leadership of interdisciplinary and international teams working in a Contract Research Organization
• You have significant knowledge in clinical research and in the conduct of clinical trials including significant knowledge in relevant regulations (ICH GCP, ISO 14155, EU CTR, MDR, FDA, etc.) 
• You have professional team leadership skills and  significant verbal, written communication and presentation skills.
• You have a significant knowledge about project management methods and tools (e.g. MS Project) and experiences with IRT and EDC systems
• You are fluent in business English.
• You have excellent keyboard skills, with experience using Microsoft Office (Word, Excel, Power Point, Outlook)
• You have a high flexibility, self-motivation and solution-orientation
• You have a high level of commitment and determination and the ability to work under pressure
• You have a high level of independence of working, self-initiative and problem solution
• You have the ability to build empathy, to motivate the teams
• You have the ability of forward thinking, to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures

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/