PlusOne

Data Management Lead - Clinical - Brabant Wallon

Company

Our client is an innovative company, located in Mont-Saint-Guibert, which is engaged in creating analytical tools with both research and clinical applications. The company strives to improve patient quality of life by supporting physicians’ and pharmaceutical/biotechnology companies’ efforts in identifying the right therapeutic for each individual patient.

Role

You are looking for a professional challenge that allows you to join a fast-moving and young company in order to work on the improvement of Clinical Data?

You want to use your technical competences in data management in order to bring your expertise for both internal R&D projects and for collaboration with customers? Rigorous, you want to build a qualitative work environment?

Plus One can offer you this great challenge:

Your key responsibilities:

  • Identify/assess Data Management external partners and Data Management systems available outside as needed
  • Manage outsourcing of Data Management activities
  • Ensure alignment of Data Management system used by the company with the strategic objectives/ needs.
  • Continually develop data management strategies.
  • Improve/develop Data Management processes (within internal team and with Sponsors) and standard operating procedures (SOP) to enable the company to deliver on its objectives
  • Ensure lessons learned are incorporated into standard processes to drive continual improvement.

While the group is being built, you act as an expert for Data Management activities for both internal clinical studies mainly and Sponsor projects to ensure their timely delivery. This includes but is not limited to:

  • Collaborate with the project team to set-up the data collection tool (eDC, ePro) that best fits company/Sponsor needs
  • Build, test and validate database.
  • Edit checks and rules specifications development
  • Development of the data management sections of the clinical study protocol or any other business document
  • Coordination and control of data collection and data cleaning up to database lock
  • Performing data reconciliation when necessary
  • Manage data transfers from or to company (including writing data transfer plans)
  • Development and maintenance of Data Management documentation related to the project
  • User guide and training material development
  • End users training and support
  • Oversee/manager vendor in case Data Management activities are outsourced
  • Proper filing of all Data Management related documents, in compliance with ICH-GCP requirements and/or SOP in application.
  • Archive databases

Profile

  • The successful candidate will be educated to a Master or PhD degree in Life Sciences or Computer Sciences.
  • Computer literate; programming skills as well as skills in the use and management of computer databases are strong assets
  • 5 years’ experience as a Clinical Data Manager is mandatory
  • Knowledge of different Data Manager platforms
  • Strong leadership skills and ideally a team leader experience
  • Experience with different methods and formats of delivering data to pharmaceutical industry.
  • CDISC/SDTM experience required.
  • Knowledge of ICH-GCPs and CFR 21 Part 11.
  • Fluent in French and English, Dutch is an asset
  • Excellent analytical and troubleshooting/problem solving skills
  • Ability to translate complex problems clearly and in nontechnical terms
  • Team player, quality focused, good communication skills and customer mindset.

Offer

The opportunity to join a fast-moving company with ambitious challenges combined with an international work environment.

Publication date

01.12.2019

Contact person

Gaëlle Minet

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