- Our company 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 us.
- Our company Services 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.
- Our company Services has also expertise in the quality control of pharmaceuticals.
- We would like to inform you that we are currently seeking candidates for the following position (m/f) : Project Manager Biometrics
Your main responsibility is to plan, organize, coordinate and control all project-related biometrics and medical affairs 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 SOP’s.
- You provide leadership to a cross-functional team in the execution of the biometrics (electronic data capture, data management, statistics, PK and medical writing) and medical affairs aspects of a project
- You serve as the biometrics primary contact to the sponsor, to the other company Services project teams and to any external biometrics provider
- After approval of the project, you ensure the creation of the project in the applicable systems
- You coordinate the assignment of a project team
- You follow-up on the biometrics activities within the scope of your project
- 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 our company.
- In case of project audits, you act as the primary contact person for the biometrics project next to the biometrics quality system coordinators
- University degree or PhD in science or relevant experience within clinical research
- At least 4 years of experience within project management in clinical research or any other relevant function within the biometrics domain in another pharmaceutical company or CRO
- Good 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 towards internal and external parties
- Ability to plan projects within the constraints of budget, sponsor requirements and resources
- Team player
- Customer minded
- Quality minded
- Willing to travel occasionally