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Senior Manager, Clinical Operations

Clinical OperationsClinical OperationsFull TimeRemoteSeniorTeam 51-200Since 2011H1B No SponsorCompany SiteLinkedIn

Location

Illinois

Posted

15 days ago

Salary

$160K - $180K / year

Seniority

Senior

Bachelor Degree5 yrs expEnglishGoogle Cloud Platform

Job Description

Senior Manager, Clinical Operations

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• Leads the planning and execution of multicenter, potentially multinational phase 1-4 clinical studies, while contributing to broader clinical strategy and go-to-market readiness. • Responsible for the project timelines, budget development and resource planning, and partners cross-functionally to ensure clinical programs are aligned with development objectives, operational excellence, and downstream commercialization needs. • Ensures timely execution and completion of clinical trials while overseeing study teams and external partners to deliver high-quality clinical trials in compliance with applicable regionals and global regulations. • Serves as the primary operational lead for assigned studies, with accountability for timelines, budgets, resource planning, and delivery of key milestones. • Leads cross-functional Study Teams, including CRO/vendor staff, ensuring alignment of clinical execution with broader development strategy.

Job Requirements

  • Accredited Bachelor's Degree
  • 5+ years of experience in pharmaceutical, biotech, or CRO industry
  • 3+ years of experience in clinical study management or monitoring (e.g., CRA, CTM, Study Manager)
  • Demonstrated experience managing global or multicenter clinical trials
  • History of managing sites in Pharma-sponsored clinical studies intended for use in NDA applications to FDA including monitoring visit scheduling, clinical site management, site training, site communication, query resolution, and generation of trip reports
  • Strong knowledge of the global drug development processes and regulatory requirements (ICH GCP, CFR)
  • Excellent written and verbal communication and presentation skills and ability to effectively work on remote cross-functional teams.
  • Ability to lead cross-functional teams and influence without direct authority
  • Strong project management skills, including planning, prioritization, and risk management
  • Ability to manage multiple priorities in a fast-paced, matrixed environment.

Benefits

  • flexible paid time off (PTO)
  • health benefits to include Medical, Dental and Vision
  • company match 401k

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