Sumitomo Pharma America, Inc.

We are united in our mission to deliver patient-needed therapies sooner.

Senior Clinical Research Manager, Oncology

Full TimeRemoteTeam 1,001-5,000H1B No SponsorCompany SiteLinkedIn

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

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