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About the Role
The role involves the overall management of clinical data management throughout the entire study cycle, with a focus on the conception, development, and validation of electronic Case Report Forms (eCRFs). You will be responsible for data validation, cleaning, and reporting, ensuring data integrity and accuracy. The position also includes oversight of external service providers and training of study centers or internal teams.
Responsibilities
- Overall management of clinical studies in data management throughout the entire study cycle
- Technical management and monitoring of the conception and development of (e)CRFs according to study protocols
- Oversight and review of eCRF validations, User Acceptance Tests (UAT), and plausibility checks (Edit Checks)
- Responsibility for the implementation and maintenance of Data Management Plans (DMP) and Data Validation Plans (DVP)
- Validation of clinical study data to ensure consistency, integrity, and accuracy
- Creation of reports and listings for Data Review, Medical Review, data transfers, and safety analyses
- Monitoring and execution of data validations and data cleaning
- Oversight of external service providers (Vendors/CROs) in data management
- Training of study centers or internal teams on eCRF and data management processes
- Independent coordination with statistics for the provision of analyzable datasets
Requirements
- Completed degree in natural sciences, biostatistics, medical informatics, computer science, or comparable
- Several years of professional experience in clinical study data management is desirable
- Ideally, experience in collaborating with external partners and vendors
- Team spirit and organizational talent, good communication skills
- Proficient German and English language skills, both written and spoken
- Very good knowledge of database structures and programming, ideally R
- Experience in the creation and validation of eCRFs in common EDC systems
- Structured, careful, and independent way of working
- Strong organizational skills, ability to prioritize and work with deadlines
- Analytical and solution-oriented thinking, and the ability to react flexibly to changing requirements
- Knowledge of ICH-GCP guidelines and relevant regulations (certified)
- Proficient German and English language skills, both written and spoken
- Proficient in using MS Office applications
Skills
- Data Management
- Clinical Studies
- eCRF Development
- eCRF Validation
- User Acceptance Testing (UAT)
- Plausibility Checks (Edit Checks)
- Data Management Plans (DMP)
- Data Validation Plans (DVP)
- Data Validation
- Data Cleaning
- Reporting
- Database Structures
- Programming (ideally R)
- EDC Systems
- ICH-GCP Guidelines
- MS Office
Location
- Mönchengladbach
- Gladenbach (near Gießen/Marburg)
- Berlin
Work Type
- Homeoffice an bis zu 2 Tagen/ Woche möglich
- Flexible Arbeitszeitmodelle
Experience Level
- Mehrjährige Berufserfahrung im Datenmanagement klinischer Studien wünschenswert
Education Level
- Abgeschlossenes Studium im Bereich Naturwissenschaften, Biostatistik, Medizininformatik, Informatik oder vergleichbares
Benefits
- Attraktives Benefit-Programm (u. a. steuerfreier Sachbezug)
- 30 Tage Urlaub (bei einer 5-Tage-Woche)
About the Company
- We are the Women's Cancer Study Group GmbH (WSG), one of the leading academic study groups in Germany in the field of breast cancer research.
- With the results of our prospective randomized studies on early breast cancer, we have helped shape the guidelines and treatment practices in Germany and internationally.
- At WSG, a dedicated, highly motivated, interdisciplinary team of medical experts, scientists, data managers, statisticians, and many others works hand in hand every day to offer patients with breast cancer individually tailored, optimally tolerated, and highly effective therapy.
- As an academic research institution focusing on the design, organization, and conduct of clinical studies in the field of breast cancer, we contribute to sustainably changing guidelines and thus the treatment of every patient in Germany – for example, by avoiding unnecessary chemotherapy while maintaining equally good survival chances.
- Become part of this successful team!