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Overview :
The Clinical Trial Manager works in close contact with the Functional Rep and gives input into Project Teams. They have extensive experience with lab studies.
He / she is interfacing with R&D, Clinical Science, Medical Affairs, Regulatory Affairs and Biometrics in the overall design validation planning.
The Clinical Trial Manager is leading the Study Team with overall accountability for study preparation, execution, and close out, thereby ensuring that the Sponsor responsibilities are fulfilled.
The Clinical Trial Manager ensures that studies are conducted to meet US / EU requirements for CE and FDA approvals or any other applicable regulatory requirements.
Responsibilities :
• Leads the global study team with full accountability for the study with respect to quality, cost and timelines.
• Develops study design for technical studies in coordination with internal / external experts and the development project team
• Provides input to study synopsis prepared by ...