Sumitomo Pharma America, Inc.
We are united in our mission to deliver patient-needed therapies sooner.
Senior Clinical Research Manager, Oncology
Location
United States
Posted
21 days ago
Salary
$137.8K - $172.3K / year
Bachelor Degree6 yrs expEnglishGoogle Cloud Platform
Job Description
• 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
Job 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
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