Senior Clinical Research Manager, Oncology

Role Overview

• Oversee the day-to-day functions of assigned Site Monitors to ensure the monitoring team is meeting project goals in compliance with GCP/ICH guidelines
• Support the Director of Clinical Operations in management of Site Monitoring Team
• Assist in periodic and annual budget forecasting for site monitoring
• Support implementation of global initiatives for monitoring training
• Participate in and may facilitate cross-functional study teams
• Coordinate with study project leads on clinical study timelines
• Provide monitoring oversight by reviewing schedules, metrics and reports
• Review monitoring visit reports and understand quality issues
• Participate in development and review of study plans and key documents
• Maintain quality at the level of investigative sites and data
• Provide oversight of TMF document collection and filing
• Contribute to study feasibility assessments and selection of countries and sites
• Mentor junior members of the team

Requirements

• Minimum of 6 years CRA experience in the pharmaceutical/biotech industry
• Bachelor's Degree Required
• Strong knowledge of ICH/GCP guidelines
• Comprehensive understanding of the drug development process
• Prior oncology drug development experience preferred
• Proficient with MS office suite
• High level of organizational skills
• Demonstrated ability to work independently in a matrix environment
• Demonstrated ability to prioritize and manage multiple tasks simultaneously
• Ability to influence through collaboration
• Flexibility to accommodate changes in priorities and project needs

Tech Stack

• Google Cloud Platform

Benefits

• merit-based salary increases
• short incentive plan participation
• eligibility for our 401(k) plan
• medical, dental, vision, life and disability insurances
• flexible paid time off
• 11 paid holidays plus additional time off for a shut-down period during the last week of December
• 80 hours of paid sick time upon hire and each year thereafter