Asssistant Director Global Trial Leader-WYETH-USA- Collegeville, PA
Global Study Leader will have ultimate responsibility and accountability for study execution. The GTL will need to collaborate and coordinate cross-functionally and cross-regionally to execute the study when taking corrective action to address major study level issues and when making major study and site level decisions. The GTL will support multiple studies and may span a program as the GTL as program size and associated workload allows.
Job Responsibilities
Plan, manage and execute study
Ensure regulatory compliance and GCP adherence at the study level
Take corrective action for major study level issues (e.g. enrollment lagging across several regions)
Make major site level decisions (e.g. final site selection) based on input from the team
Plan, facilitate, and lead study team meetings
Provide direct input into the protocol writing process on operational aspects
Accountable for protocol execution across a study
Provide input during budget creation to GCPL
Manages budget during study execution
Creates and drives study level timelines
Develops study level enrollment plan