Sumitomo Pharma America, Inc.

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

Associate Director, Study Start-up, Oncology

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

Location

United States

Posted

5 days ago

Salary

$150.8K - $188.5K / year

Bachelor Degree8 yrs expEnglishGoogle Cloud Platform

Job Description

• Accountable for the end-to-end delivery of site start-up activities across clinical studies, from site identification through site activation. • Work in close collaboration with the Clinical Project Manager (CPM) and/or Clinical Operations Study Lead. • Lead the strategy development and execution of global site identification, feasibility, and selection for new and ongoing oncology trials. • Collaborate with cross-functional stakeholders and external vendors involved in site selection and activation processes. • Oversee the preparation and execution of CDAs, site contracts, and ICFs.

Job Requirements

  • Minimum of 8 years of experience in clinical drug development, clinical program management, or equivalent academic experience in clinical trials.
  • Bachelor’s degree in a related discipline (preferably life sciences) or an equivalent combination of education and experience.
  • Comprehensive knowledge of ICH-GCP and international clinical trial regulations; working knowledge of GMP/GDP principles.
  • Thorough understanding of oncology clinical research and operational considerations.
  • Working knowledge of current global regulatory requirements and guidelines governing clinical trials.

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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