Project Manager Biometrics
Mechelen, Vlaanderen, Belgium
1 dag geleden

SGS is the world’s leading inspection, verification, testing and certification company. The company employs over 90 000 people and operates a network of more than 1 000 offices and laboratories around the world.

In Belgium 1.650 people are working for SGS.

One of the business segments, Life Science Services , is a leading contract research organization (CRO) offering Clinical Research Services to the pharmaceutical and biopharmaceutical industry.

We are currently looking for candidates for the following position :

Project Manager Biometrics (m / f)

The Project Manager Biometrics manages a cross-functional team in the execution of the biometrics and medical affairs (medical review and pharmacovigilance) aspects of a clinical trial.

Your main responsibility is to plan, organize, coordinate and control the project-related biometrics activities in order to achieve all the objectives described in the contract within the constraints of timelines and budget and with respect to ICH-

GCP and the applicable procedures.

This implies that :

  • You serve as the biometrics primary contact to the sponsor, to the other SGS Life Science project-related teams and to external biometrics providers as applicable for the project.
  • You coordinate the assignment of a project team and the creation of the project in the applicable systems.
  • You follow up together with the project team on the status of the project towards the defined deliverables.
  • You are responsible for regular budget review in order to make sure that budget stays in balance with the work performed, forecasting and appropriate invoicing according to the contract.
  • You will actively review any changes to the scope of the project and will be responsible for discussing changes in scope with the sponsor and initiating the change order process at SGS.

  • In case of project audits, you act as the primary contact person for the biometrics project related activities next to the biometrics quality system coordinators
  • University degree, PhD in Science or relevant experience within Clinical Research
  • At least 2 years of experience within project management or any other relevant function in another pharmaceutical company or CRO
  • Knowledge of the different biometrics activities is an asset
  • Fluently writing and speaking English. Other languages (Dutch, French) are an asset
  • Good knowledge of MS Office
  • Stress resistant and flexible
  • Excellent communication skills and problem solving skills
  • Ability to plan projects within the constraints of budget, sponsor requirements and resources
  • Quality minded
  • Willing to travel occasionally (attendance at kick-off meetings)
  • Are you interested or do you know somebody who might be?

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