As a Clinical Data Manager you will play a key role in ensuring high-quality clinical data throughout the lifecycle of our studies. Youll 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 :
- Bachelors 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 IIV 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 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