Parexel

Manager, Clinical Operations

Parexel

full-time

Posted on:

Location Type: Remote

Location: Romania

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About the role

  • Manage integration of project team activities
  • Provide input on trial level operational strategies for clinical trials
  • Relationship management between study sites and vendors
  • Manage aspects of CRO/vendor identification and day-to-day operational management activities
  • Manage strategic study operations including study sites and tracking systems
  • Create and update critical trial-specific documents
  • Support development of compound and protocol level training materials
  • Review and provide input into budgets, timelines, and forecasts for assigned clinical studies
  • Interface with internal key stakeholders for effective collaboration
  • Provide support for inspection readiness activities and risk mitigation plans
  • Participate in process improvement activities
  • Support onboarding of new team members

Requirements

  • 5+ years of clinical research experience with a CRO, Biotech, or Pharmaceutical Company working on Phase 1-4 global clinical trials
  • 2-3+ years leading aspects of global clinical trials (CTM, COL or similar)
  • Experience working with a CRO
  • Strong regulatory knowledge, including Good Clinical Practices (GCPs)
  • Strong decision-making, analytical and financial management skills
  • Proven ability to foster team productivity and cohesiveness
  • Experience in leading without authority in multifunctional matrixed and global environments
  • Experience mentoring/ coaching others
  • Exceptional organizational skills and ability to deal with competing priorities
  • Strong project planning/ management, communication (written and verbal) and presentation skills
  • Proficient with MS Office Suite (Excel, Word and PowerPoint)
Benefits
  • Exceptional financial rewards
  • Training and development
  • Healthy work-life balance
  • Supportive work environment
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical researchglobal clinical trialsregulatory knowledgeGood Clinical Practices (GCPs)project planningfinancial managementanalytical skillsmentoringcoaching
Soft Skills
decision-makingteam productivityorganizational skillscommunication skillspresentation skillsrelationship managementprocess improvementcollaborationability to deal with competing priorities