Miltenyi Biomedicine is a newly established international biopharmaceutical company that develops innovative cell and gene therapies. We are focused on bringing cancer treatments and regenerative therapies to patients. Our initial focus is on difficult to treat hematological cancers using CAR-T technology whilst exploring treatments for solid tumors. We are currently in discussion with the FDA, EMA and Japanese health authorities regarding initiating pivotal Phase II trials. We strongly believe that despite promising developments, there is significant room to improve on current cancer therapies.
Contribute to all data management aspects across the life-cycle of assigned clinical trials including start-up, enrollment, data cleaning and data delivery.
Develop Data Management Plans, Data Validation Plans, and External Data Transfer Specifications that will deliver accurate, timely, consistent, and quality clinical data.
Be involved in the validation of eCRF and ensure compliance of computerized systems with applicable regulations, data standards (i.e. CDISC CDASH) and study requirements for data collection.
Create and revise Standard Operating Procedures for data management.
Join the clinical trial teams and ensure that data management services are delivered in a consistent, high-quality manner.
Minimum BS in a scientific or health related field or equivalent.
Minimum 5 year experience in clinical data management. Oncology experience is a plus.
Routine in dealing with EDC systems (ideally MARVIN)
Sound knowledge of all relevant guidelines and aspects of clinical data management.
Excellent verbal and written communication and interpersonal skills.
What we offer
A modern workplace and exciting opportunities in the development of technologies with a secure future
Cross-border intercultural cooperation and short communication channels
A collegial corporate culture and flexible working hours enable time management on your own terms
Personalized employee development program: specialist and personal training courses provided by our own training academy
Diverse corporate benefits with regard to employee health, sport, and staff events
If you have the skills and qualifications for this position, please use the link to send us your details (application letter, curriculum vitae, references and certificates). Please give us some idea of when you can start and the kind of salary you are looking for.