* Oversees and manages clinical team in U.S. and Europe to ensure alignment of activities with study/project timelines and to provide overall oversight of activities requiring GCP compliance.
* Identify project objectives, identify potential obstacles and propose innovative solutions, and ensure adequate resources are implemented to ensure successful completion of the project.
* Manages external resources such as consultants, contractors, CRO's.
* Coordinates vendor meetings and review vendor documents for adequacy.
* Develops Project Plans to include timelines and milestones.
* Prepares Clinical documents (e.g., protocols, study reference manuals, documents to be submitted to Regulatory agencies or ethics boards), Standard Operating Procedures, guidelines, and departmental policies.
Sthree US is acting as an Employment Business in relation to this vacancy.