(Senior) Clinical Data Manager - Antwerpen

Vacancy information

Publication date:September 21 2020
Employment type:Permanent
Sector:Clinical Research
Function Group:Clinical Research

Function Group: Clinical Research / Data Manager

Organization

For one of the most innovative and inclusive clinical research organisations in Europe, we are currently looking for a strong and driven (Senior) Clinical Data Manager, who will work near Antwerp. With close to 100,000 employees working at more than 1,000 locations around the world this organisation is truly changing people’s lives. On a daily basis they coordinate and run clinical trials for their highly respected pharmaceutical and biotech partners.

Function

As an experienced Clinical Data Manager, we are looking for a Data Management Lead who is responsible for all the data management activities from the projects of 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 trustworthy, transparent, clean, and consistent SDTM data is delivered to the Statistical team at database lock.

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

  • Reviewing and testing of the Data Collection Tool (EDC Tool or eSource Tool)
  • Create eCRF completion Guidelines and provide EDC training at investigator meetings
  • 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 (customised) 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

Requirements

As the ideal candidate you have the following profile:

  • A university degree or PhD in life sciences/medical, with at least two years of experience in Clinical Trial Data Management in a pharmaceutical or biotech company or another CRO
  • You have great eye for detail, are data minded, and are a strong communicating team player
  • You love to lead and motivate a team, work within this team and also independently
  • You have a strong command of the English language both verbally and written
  • You are quality minded and respond well to stress and work pressure

Offer

On offer is:

  • A great salary package
  • Great additional benefits such as meal vouchers and various insurances
  • The chance to work in a professional environment that promotes personal and career growth in the form of extensive trainings

Application

Do you think and breathe Data Management? Then do not hesitate and contact me immediately via de below details!

Martin van der Velden
Principal Associate Biotech/Pharma division

+31(0)6-83656209
+31(0)23-7548660
m.vandervelden@qtcrecruitment.com

Apply

Contact

To find out what QTC Recruitment can do for you, please contact us. 
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