Clinical Data Manager (m|f|d) Fixed-term, 24 months

Bergisch Gladbach, Germany

⚠️ We'll shut down after Aug 1st - try foo🦍 for all jobs in tech ⚠️

Apply now Apply later

Company Description

Miltenyi Biomedicine is a biopharmaceutical company committed to advancing personalized cell and gene therapies. We are pioneering groundbreaking therapies for serious life-threatening diseases, and reshaping their accessibility for clinical professionals and patients worldwide with the aim to improve and extend patients' lives. We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases.  Our lead candidate, a tandem CAR T-cell product, is currently undergoing pivotal clinical trials on a global scale. 

Join our highly professional team in bringing new medicines to market and ensuring the safety of our pharmacological developments at all stages. 

Job Description

As a Clinical Data Manager, you will play a key role in ensuring high-quality clinical data throughout the lifecycle of our studies. You’ll contribute to the foundations of our clinical data infrastructure and lead efforts that directly impact patient outcomes. 

In your role, you will:  

  • Develop and maintain study-specific Data Management Plans (DMPs) and lead the specification and testing of EDC databases, including eCRF design and validation. 
  • Participate in the review of clinical study documentation (e.g. protocols, CRFs, statistical analysis plans). 
  • Coordinate external data transfers and ensure reconciliation with internal databases (e.g. laboratory, safety data). 
  • Support user management, training, and user acceptance testing (UAT) execution for clinical trial databases across multiple studies. 
  • In addition, you will organise cross-functional collaboration with internal and external stakeholder to support database lock, statistical review, and audit-readiness, and to ensure smooth data flow and timely issue resolution. 

Qualifications

  • Bachelor’s degree in a science-related field or comparable qualification and proven practical experience in clinical data management within the pharmaceutical, biotechnology, or medical device industry. 
  • Hands-on experience with Phase I–IV clinical trials and working knowledge of GCP and clinical trial processes. 
  • Proficient in clinical data systems (e.g. EDC, CTMS) and relevant standards (e.g. MedDRA, CDISC). 
  • Strong communication and organizational skills with the ability to coordinate across different stakeholders. 
  • Experience in database validation and collaborating with internal stakeholders and external service providers. 

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 world’s most serious health challenges. And that’s 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. 

 

Apply now Apply later

* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰

Job stats:  0  0  0
Category: Leadership Jobs

Tags: CDISC Data management GCP Pharma Statistics Testing

Perks/benefits: Health care Insurance

Region: Europe
Country: Germany

More jobs like this