Uses performance metrics and quality indicators to assist the Global Trial Lead (GTL) in driving study execution.
Resolves routine problems and escalates important issues appropriately (with a sense of urgency).
Actively contributes as a key functional member on cross-functional teams.
Study/Project Planning, Conduct and Management
Understands study level tools and plans.
Manages the development and/or collection of study level documentation and supports GTL in ensuring eTMF accuracy and completion for all studies.
Provides and support input to study level tools and plans while working with moderate to minimal supervision, including but not limited to the Transfer of Obligations to Regulatory authorities. Study SharePoint/study directory updates and the Global Vendor Site List etc. ...