Project Manager – Start-Up

Project ManagerProject ManagerOtherRemoteLeadTeam 10,001+H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

3 days ago

Salary

$110K - $130K / year

Seniority

Lead

Bachelor Degree8 yrs expExperience acceptedEnglishGoogle Cloud Platform

Job Description

• Accountable for execution and oversight of local operational clinical trial activities. • Ownership of country and site budgets. • Development, negotiation, and execution of Clinical Trial Research Agreements (CTRA). • Oversight and tracking of clinical research-related payments. • Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. • Work in partnership with IRB/IEC and Regulatory Authority in submission and approval related interactions for assigned protocols. • Provide oversight and tracking of clinical research-related payments. • Responsible for managing country deliverables, timelines, and results for assigned protocols to meet country commitments.

Job Requirements

  • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
  • In lieu of the above requirement, candidates with a minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
  • Thorough understanding of the drug development process.
  • Fluent in local office language and in English, both written and verbal.
  • Minimum of eight (8) years of clinical research experience and SSU work 3+ years of SUPM experience Global submissions experience.

Benefits

  • Medical
  • Dental
  • Vision
  • Life
  • STD/LTD (multiple insurance carriers)
  • 401(K)
  • Paid time off (PTO) – Flex Plan
  • Employee recognition awards
  • Multiple ERG’s (employee resource groups)

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