About this role:
As an experienced CDM you are the Data Management (DM) Lead who is, overall responsible for all the DM activities from the projects on which you are assigned. You are the owner of the clinical SDTM database for your clinical studies and will serve as the Point of Contact towards all involved parties and towards the client. You ensure that trustful, transparent, clean and consistent SDTM data is delivered to the Statistical team at database lock.
- Review and testing of the Data Collection Tool (EDC Tool or eSource Tool)
- Create eCRF completion Guidelines and provide EDC training at investigator meeting
- Attend the Kick-off Meeting with the client and involved parties
- Development of Data Management Plan
- Defining and validating the SDTM cleaning package Validation of the SDTM database based on the applicable implementation guide and agreed standards with the client Define and agree on (customized) progress and status reports
- Create/review the Data Transfer Agreements with all External Data Providers
- (Ensure the) data cleaning of subject data by generating queries towards the sites/investigators (check on inconsistent, missing, incorrect or unclarified data)
- Coding of therapies and medical events Serious Adverse Event reconciliation
- Create the Protocol Deviation Criteria List and handle/detect the Protocol Deviations (minor/major)
- Communication with all involved parties (EDC, STAT, MA, Clinical teams, Client, External Data Providers, Medical Writing, Project Manager Biometrics) …
- Processing of (Interim) Database Locks and provide the necessary data for Safety Reviews, DSMBs, Safety Committees
- Ensure the submission package is complete for your project
What you need to bring:
- Master/PhD of Science (Biomedical Sciences, Bio Engineering, Epidemiology, Pharmaceutical Sciences, Biology, … )
- Fluent and proficient knowledge of English
- Data minded
- Eye for detail
- Very proficient communication skills
- Stress resistant
- A real team player
- Preferably, a minimum of 2 years of experience within Clinical Trial Data Management is required.
Our network and expertise make it possible for us to advance your career. Brunel has a reputation of working with some of the best in the business. That's what we continually strive for. Over 40 years, we've created a global network of interesting clients and talented individuals working together through a vast array of services.
Start applying immediately
Sending an application is quick and easy. Just make sure you have the required documents ready to go.
- Job references (optional)
- Motivation Letter (optional)
Any questions remaining?
Your consultant, Elke Binst is happy to clarify anything about this vacancy. When reaching out, use this number:
Brunel Belgium Mechelen
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