Secure Data Manager - Antwerpen

Introduction

For our client, a Clinical Research Organisation near Antwerp, QTC Recruitment is currently on the look out for a Secure Data Manager

Being in integral part in innovative research and as a result improving people’s lives, that’s what this organisation is all about.

Organization

At the Secure Data Office, all data that is unblinding in nature is handled (i.e. pharmacokinetic concentrations, pharmacodynamic data, immunogenicity data, …) Data is received from the bio-analytical labs and this is combined this with patient data captured at the clinical sites. This data is turn will be converted into the standard file format. The link between the labs, the data management companies and the pharmaceutical companies!

Function

As Secure Data Manager you will be responsible for the transfer of unblinding data from and to the Secure Data Office and the cleaning of unblinding data within the Secure Data Office. These responsibilities encompass the creation of data transfer agreements, data cleaning documentation and the specification of edit checks and listings. The Secure Data Manager also performs the QC of unblinding data, the cleaning of the data in EDC and/or clinical database and the creation/follow-up of edit checks. In addition to the above mentioned activities, the Secure Data Manager will also be responsible for the handling of randomisation lists (upload of randomisation list in internal IWRS system, release of randomisation list at database lock, emergency unblindings, distribution of randomisation list to third parties,…)

In addition you will:

  • Liaise with clients and external service providers
  • Organise and lead kick-off meetings and teleconferences with the clients
  • Discuss specifications about the lab data and the patient data we receive and the expected format that we are delivering
  • Creation of Data Transfer Agreements for external data
  • Support in Quality control
  • Actively contribute to process improvement

Requirements

The ideal candidate:

  • Has a Master’s, holds a PhD degree in sciences or has relevant experience in the field
  • has a strong command of the English language
  • Is very accurate, has eye for detail and is quality minded
  • Has a flexible attitude and is communicatively strong
  • Has a positive, constructive, professional attitude towards colleagues, team members and clients
  • Possesses good time management skills and is stress resistant

Offer

Besides a really competitive salary, other benefits are

  • Meal vouchers
  • Insurance package
  • Car and gas card
  • Flexible working hours
  • 20 days annual leave + another 12 time reduction days

Information

Are you the one I’m looking for? Take a look at my details below and let’s have a chat!

Application

Martin van der Velden
Consultant Clinical Research & Medical Affairs

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

Apply
 Share on Social Media

Contact

To find out what QTC Recruitment can do for you, please contact us.  
Contact us 
1
×
Hello, how can I help you? I will answer you as soon as possible during working hours.

Press the WhatsApp button again...