SGS Group Belgium

(Senior) Clinical Data Manager (CDM)

Mechelen
Contract duration unspecified
Full Time

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 in to 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 more than 90 000 colleagues worldwide, with 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 Life Sciences 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. SGS Life Sciences has also expertise in the quality control of pharmaceuticals.

In the spirit of continued growth and to help improve our business, we are currently seeking for a (Senior) Clinical Data Manager (CDM).

Job Description

As an experienced CDM you are the Data Management 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.

This includes, but is not limited, to following tasks:

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

Qualifications

What do you need to be successful?

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
Well-organized
A real team player
Preferably, a minimum of 2 years of experience within Clinical Trial Data Management is required.

Additional Information

What we have to offer:

Were you already considering a big switch in your career? Maybe this could be your next step. At SGS you can count on an interesting position where you can take responsibility. Come enjoy our fun team of colleagues and on top of that, we will reward you with an interesting salary package (incl. retirement plan, meal vouchers, …)

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. Send her an e-mail at heidi.aerts@sgs.com