Are you a proactive Data Manager with experience in clinical research environments and would you like to be responsible for building our (international) clinical study databases and deliver high quality data for further improvement of the best treatment and care? Then our Trial and Data Center team is looking for you!
The Princess Máxima Center for Pediatric Oncology is a research hospital concentrating healthcare, research, and education of pediatric cancer. Our institute, based in Utrecht brings together the best possible care and scientific research, creating a unique interdisciplinary institute for pediatric oncology in Europe.
One of the strategic ambitions of the Princess Máxima Center for the coming years is early phase drug research, with the focus on immunotherapy and brain tumors. This requires further growth of the TDC.
Within the TDC we are looking for a Clinical Data Manager to expand our Data Management team.
The Trial and Data Center (TDC)
Clinical research is essential for the realization of the mission of the Princess Máxima Center for pediatric oncology: improving the treatment and care of children and young adults with cancer (100% cure with less side effects). More than 100 clinical studies are currently ongoing within the Princess Máxima Center. The Trial and Data Center (TDC) coordinates and supports all these studies, with the aim to ensure high-quality research for further improvement of treatment and care. The TDC is headed by Dr. H. van Tinteren and Prof. Dr. C.M. Zwaan.
The position
As a Clinical Data Manager you are responsible for the design and development of case report forms (CRFs) and associated databases for the purpose of registration of data collected in local and international studies sponsored by the Máxima. The tasks are diverse and can differ per type of study. The research is conducted in accordance with international laws and guidelines on data collection and capture, which are implemented in the Standard Operating Procedures. Databases are being set up according to the CDISC standards. The work is performed in close collaboration with the principal investigator of the study and the participating sites within and outside of the Netherlands.
A selection of your tasks and responsibilities:
- Conduct and coordinate all data management study related activities from database set up to database lock
- Collaborate with data managers, clinicians and other specialists within the Máxima, the pharmaceutical industry and international sites
- Design,build and maintain CRFs and database validations with operational platforms: CASTOR, OpenClinica and ALEA
- Participate in CRF standardization initiatives to standardize the data according to CDISC (CDASH / SDTM)
Profile
We are looking for a proactive multitasker with good problem-solving skills. You are no stranger to the clinical research field and know how to make independent choices in a high demand environment. Therefore, you know how to communicate with multiple levels in the organization.
- Experience with database design in EDC systems
- Experience as clinical data manager in a hospital or pharmaceutical industry\
- Academic education or equivalent in the (para)medical field or life sciences
- Knowledge of Good Clinical Practice (GCP) and applicable clinical research regulations
- Experience with conduct of clinical research
- Knowledge of CDISC (CDASH/SDTM) is an advantage
- Experience with SAS programming is an advantage
- Fluency in English (Dutch is an advantage)
- Located in The Netherlands
Working at the Princess Máxima Center for Pediatric Oncology
We offer a Central Data Manager position (we use the internal title of Central Data Manager) in an inspiring, multidisciplinary research environment. The position is based on 32-36 hours per week. You will start in a temporary position for the duration of one year, with the possibility of extension. The salary depends on past education and relevant work experience. This will be FWG 55 (as per the collective labor agreement ‘cao Algemene Ziekenhuizen’). In addition, you will receive 8,33% holiday pay and 8,33 % end-of-year bonus.
Are you excited about the position?
We would like to meet you! You can apply for this position before May 15 by pressing the apply button on this screen. You are welcome to contact Rinke Riezebos, Team lead Data processing TDC, for additional information about the vacancy by email or via tel. 06 500 066 48.
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