This position will have 1-2 direct reports.
Responsibilities will include
* Managing any of the study team activities which may include investigator recruitment/selection, study start-up enrollment and reports, consistent with approved budgets/timelines
* Manages and/or oversees the management of study sites, ensuring protocol and regulatory compliance
* Works with clinical contracting group in development of RFPs and vendor selection
* Manages staff who oversee multiple vendors, including; clinical services, data management, bio-statistical services, and central laboratory services. Responsible for ensuring external service providers execute activities in a quality manner and per the established contract
* Ensures SOPs
* Participate in the development and review of study plans (e.g. CMP, DMP, SMP), study reports, protocols, ICFs, sections for Investigator's brochures, and other regulatory documents (e.g., IND, NDA or BLA) on one or more trials
* Manage CRAs/CTAs
* Assist with the coordination of data review with cross functional team to support database lock
* Initiates and participates in leading departmental or interdepartmental strategic initiatives and process improvements
* Vendor/site management