hbo Clinical Study Manager vacatures

Clinical Data Manager

Are you a proactive Clinical Data Manager with experience in clinical research, always aiming to deliver high quality data and sustainable approaches for further improvement of the best treatment and care? Then our Trial and Data Center team is looking for you!

The position

As a clinical data manager you will be mainly responsible for designing and developing electronic case report forms (eCRFs) 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 depending on the 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 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 data management study related activities from database set up to database lock together with colleague data managers
• Collaborate with trial managers, local data managers, clinicians and other specialists within the Máxima, the pharmaceutical industry and international sites
• Participate in CRF standardization initiatives to standardize the data according to CDISC (CDASH / SDTM / ADaM)
• Design, build and maintain CRFs and database validations with operational platforms: CASTOR, OpenClinica, ALEA and Veeva Vault

Profile

We are looking for a proactive multitasker with good problem-solving skills. A creative, out-of-the-box thinker who brings innovative ideas for process optimization. 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.

Furthermore, you are or have:

• 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 standards and experience of mapping data to SDTM is an advantage
• Experience with SAS programming, SQL, R and/or Python and familiar with data visualization tools is an advantage
• Fluency in English (Dutch is an advantage)
• You are already located in The Netherlands

Our offer

We offer a Clinical 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 in 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.

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 of ensuring 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 Princess Máxima Center

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.

Are you excited about the position?

We would like to meet you! You can apply for this position by clicking the apply button on this screen beforeFebruary 26 . You are welcome to contact , TDC, for additional information about the vacancy.