Group Leader – Clinical Operational Excellence (m|f|d)

As Group Leader Clinical Operational Excellence you will lead a team of experts and take ownership of driving operational excellence across our European Clinical Development organization. In this strategic role: 

• You will  lead and coordinate clinical operational excellence initiatives including inspection readiness initiatives across Clinical Development EU ensuring compliance with GCP SOPs and regulatory requirements while driving efficiency and high-quality standards. 
• Together with your team you will oversee TMF services trial oversight- and training requirements for clinical studies including Key Peformance Indicator management TMF vendor oversight and proactive risk mitigation. 
• In addition you will drive innovative approaches with focus on clinical trial oversight- TMF- and trial training strategy and ensure bestpractice implementation.
• Next to this together with your team you will identify and implement process improvements lead cross-functional initiatives to standardize clinical operations and ensure proper Training Coordination to maintain accurate training records. 
• You will support the ClinDev EU team with   audits and regulatory inspections by preparing documentation tracking CAPAs and reviewing trial-related manuals and plans to communicate quality requirements. 
• In this leadership position you will collaborate closely with Clinical Trial Management Data Management QA and vendors providing structured leadership through goal setting coaching and performance reviews. 
• Finally you develop effective relationships with internal and external stakeholders and work in a dynamic environment to continuously improve operational processes and compliance standards. 

Qualifications :

• You hold a university degree in Life Sciences Natural Sciences or a related healthcare field and bring proven experience in clinical operations within the pharmaceutical or biotech industry. 
• You have a strong track record in sponsor oversight for Phase II/III trials and hands-on TMF (eTMF) management with measurable improvements in quality completeness and timeliness. 
• You possess in-depth knowledge of ICH E6(R2/R3) EU CTR EMA/FDA inspection behaviors SOP governance and trial-specific oversight plans and you are skilled at prioritizing multiple tasks to meet timelines. 
• You are a strong and experienced leader with proven disciplinary and functional management skills demonstrating excellent organizational abilities and fostering collaboration across clinical teams and vendors. 
• You communicate effectively in English (German is a plus) enjoy working in a dynamic environment and demonstrate pragmatic risk-based decision-making with a solution-oriented mindset. 
• You are a motivated and open-minded team player with strong interpersonal skills and the ability to thrive in complex fast-paced settings. 

Additional Information :

What we offer 

• Working with free and self-determined time management also mobile working  
• An intercultural environment characterized by diversity and flat hierarchies  
• Freedom to contribute creatively and play an active role in shaping the company    
• Individual further training in our Miltenyi University as the core of the Miltenyi DNA   
• 30 days of vacation discounted ticket to Germany (e)-bike leasing capital-forming benefits company pension plan disability insurance canteen and much more. 

Diversity is the bedrock of our creativity 

Our mission: To innovate treatments and technologies and tackle the worlds most serious health challenges. And thats why we connect the dots across various disciplines linking different perspectives skills and abilities. 

You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender sexual identity age ethnicity religion or disability. 

Become part of our team and focus on pushing the borders of medicine. 

We look forward to your application 

If you want to work in an open creative and supportive team this is the place for you. We look forward to receiving your application along with your salary expectations and availability. 

Remote Work :

No

Employment Type :

Full-time