Senior Regional Study Manager Companion Diagnostics
Core
Coordinate and oversee regional companion diagnostic (CDx) study activities from initiation through closure, serving as the primary liaison between diagnostic sponsors, laboratory operations, and clinical research teams.
Role type
Senior Regional Study Manager (Companion Diagnostics)
Builds
Regional execution of companion diagnostic studies for pharmaceutical sponsors and health systems
Domain
Clinical Laboratory Services / Companion Diagnostics / Pharmaceutical Research
Deliverable
client delivery
Required skills
project management, regulatory compliance, study lifecycle management, stakeholder liaison, audit support, billing tracking, adverse event reporting, documentation management, inventory control
Preferred skills
ASCP or PMP certification, multidisciplinary lab background, pharmaceutical industry project support
Technologies
business and project management systems
Responsibilities
Coordinate regional CDx study activities from initiation to closure; Manage regional study deliverables with global teams and lab operations; Serve as primary liaison among sponsors, investigators, and lab sites; Review Statements of Work for local feasibility; Monitor study timelines and coordinate cross-functional activities; Prepare and host client and clinical research associate site visits; Support client audits; Submit regulatory authority applications; Track billing activities and study metrics; Report adverse events and protocol deviations; Maintain and archive study documentation; Perform physical inventory activities for study materials
Seniority
Senior, hands-on IC
