Senior Manager Clinical Study Lead

Leads the cross-functional study team responsible for clinical study delivery
Provides operational input into protocol development
Oversees and provides input to the development of study specific documentation
Ensures compliance with the clinical trial registry requirements
Identifies outsourcing needs of the study and leads engagement with vendors
Provides input into baseline budget and timeline development
Leads risk assessment and identifies risk mitigation strategies
Oversees site evaluation and selection
Monitors progress for site activation and monitoring visits
Leads the development of patient recruitment and retention strategies
Ensures accurate budget management and scope changes
Oversees study drug and clinical supplies forecasting
Escalates issues related to study conduct, quality, timelines or budget
Oversees data quality and ensures CROs and Third Party Vendors are aligned
Supports internal audit and external inspection activities
Manages and oversees study close-out activities
Contributes to clinical study report writing and review
Facilitates and contributes to study level lessons learned
Assigns tasks to Clinical Study Management staff
Recommends and participates in process improvement initiatives
Responsible for identification of innovative approaches to clinical study execution
Responsible for direct supervision of CTM staff