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Lupus Research AlliancePosted 1 month ago

Clinical Trial Manager, Lupus Therapeutics

$85,000–$115,000 year

HybridNew York City, New York, United States or New York, United States

Full TimeSmall

Job Summary

Lead and direct cross-functional teams and vendors to ensure compliance with study protocols and corporate timelines. Serve as the primary interface between LuCIN sites and research partners, identifying concerns regarding study startup or conduct and escalating them to stakeholders. Schedule and lead project conference calls with investigators and site staff to provide status updates, conduct training, and maintain accountability for deliverables. Independently develop analysis, projections, and financials for senior management while managing project deliverables against contractual agreements. Establish and implement study plans to support study management with vendor partners and facilitate budget and contract negotiations. Conduct site feasibility evaluations, monitor site performance, and prepare accurate visit reports. Track performance metrics regarding enrollment and engagement, offering strategic advice for study communications. Submit a cover letter and CV; Bachelor's degree and three to five years of clinical trial experience required.

Required Qualifications

  • Bachelor's Degree
  • Three to five years of clinical trial experience with increasing levels of responsibility in the academic research, pharmaceutical, biotechnology, or CRO industry
  • Exposure to the clinical trial environment
  • project management role with contract and budget experience
  • Thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and data management methods
  • Excellent verbal and written communication skills
  • Good team player
  • Excellent negotiation and conflict resolution skills
  • Critical thinker
  • Self-motivated
  • Quick learner
  • Organizational skills to work efficiently and manage multiple ongoing projects
  • Proficiency with MS Office suite (Word, Excel, PowerPoint, and Outlook)
  • Limited travel as required (North America) for site visits, conferences and team meetings

Desired Qualifications

  • Therapeutic experience in autoimmune diseases and/or Lupus
  • Cover letter
  • CV/resume

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