Clinical Data Manager

Company Description

At SGS, you can choose.

First of all, out of our various vacancies.

However, SGS also gives you another choice.
Do you choose to expand or to enrich? We are not only looking for colleagues who can go into depths of their discipline. We are equally as much looking for colleagues who we call ‘connectors’, people who can connect our diversity to our services. To each other. And this way, enrich our business.

SGS is the world’s leading inspection, verification, testing and certification company. We’re also the benchmark worldwide for quality and integrity. And that makes us very proud. This can only happen thanks to almost
100 000 colleagues worldwide, with more than 1650 employees in Belgium only. Our employees give 110% of themselves every day, divided over all expertises, branches and cultures.
Our coworkers build their own way inside the company, the services and the expertise.

SGS Pharma carries out all type of services for pharmaceutical and biotechnology companies, from coordination and running of clinical trials with new molecules or techniques on human beings, to support and consultancy on post marketing registration activities.

Grow in a company that is the home of global knowledge and expertise; that operates in a wide range of countries, services and sectors; and that offers you endless opportunities to learn, grow and fulfill you potential!

In the spirit of continued growth, we are currently looking for a Clinical Data Manager!

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 set-up 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
Well-organized 
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 work-life 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 (heidi.aerts@sgs.com).

Please only apply via the apply button and not via mail.
Please note we cannot support a work permit procedure or relocation.