Clinical Data Manager
Clinical Data Manager
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Job Description
In this role you act as the Data Management Lead overall responsible for the Data Management (DM) activities on your clinical trial and you are the DM contact for all stakeholders.
You are working together with the Data Programmer for the setup of the clinical data management systems (CDMS) in which all data of your trial will be loaded and processed. You are responsible for the delivery of clean consistent complete submittable and reliable clinical trial datasets to the statistical team the client and other parties.
You keep the client up to date on the status and progress of the trial with regards to Data Management.
This includes (but is not limited to) following tasks:
- Review of the Data Collection Tool (EDC Tool or eSource Tool)
- Creation of the Data Management Plan
- Communication with all involved stakeholders (client external data vendors clinical and biometrics trial teams medical monitors sites)
- Defining and validating the programmed cleaning rules in the Data Validation Plan
- Creation and validation of Data Transfer Agreements with all external data vendors (Central Labs ECG provider ePRO )
- Validation of the clinical SDTM database based on the applicable regulation standards
- Data cleaning through review of the rules output Query handling to the sites/investigators
- Reconciliation of laboratory and other external vendor data
- Coding of medications and medical events
- Serious Adverse Event reconciliation
- Define and detect Protocol Deviations
Qualifications :
Master / PhD in Biomedical Sciences Epidemiology Pharmaceutical Sciences Biology
Biomedical Engineering
Fluent in English and a proficient knowledge of Dutch
Interest in working with data(bases)
Likes to solve problems!
Accurate mindset
Dedicated and persistent
Good communication skills
Stress resistant
Wellorganized
A real team player
Additional Information :
What can you expect
- An interesting position where you can grow and take responsibility. A professional team of colleagues where you can take your chance to be part of a knowledgeable and dedicated team!
- An organized and intensive training traject
- A good worklife balance
- Growth perspective towards an expert role or a coordinating position
- Great colleagues and an open atmosphere!
Please note we cannot support a work permit procedure.
Do you want to be part of this
We are looking forward to hearing from you!
Send us your story and your resume via the apply button and maybe you will soon join us for work and coffee breaks. Still have questions Heidi Aerts can give you more details about the job ().
Please only apply via the apply button and not via mail.
Please note we cannot support a work permit procedure or relocation.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
