Sumitomo Pharma America, Inc.

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

Senior Manager, Clinical Data Management

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

Location

United States

Posted

27 days ago

Salary

$151K - $188.7K / year

Bachelor Degree8 yrs expEnglishGoogle Cloud Platform

Job Description

• Provide timely and professional ongoing management of project and clinical trial data. • Work closely with outsourced clinical data management (CDM) activities with various Contract Research Organizations (CROs). • Ensure study team expectations are clearly communicated to the CRO. • Provide comprehensive data management expertise to deliver efficient data management products. • Serve as the Lead Data Manager on studies. • Understand and comply with core standard operating procedures (SOPs). • Review and approve various CDM documents. • Communicate ideas for process improvement. • Provide project updates to management weekly and monthly.

Job Requirements

  • Minimum 8 – 12 years (without Master’s) or 6 – 8 years (with Master’s) of relevant experience in biotech or pharmaceutical industry.
  • Thorough knowledge of the data management process.
  • Thorough understanding of clinical trial methodology, GCP and medical terminology.
  • Electronic Data Capture (EDC) experience, preferably Rave EDC
  • Requires a high level of initiative and independence.
  • Excellent written and oral communication skills required.

Benefits

  • merit-based salary increases
  • overtime
  • short incentive plan participation
  • eligibility for 401(k) plan
  • medical, dental, vision, life and disability insurances
  • up to 120 hours of vacation per year
  • 11 paid holidays
  • 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
  • access to service recognition program

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