Global Study Associate Director

Posted 3 days ago

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About the role

  • Global Study Associate Director overseeing oncology clinical trials for ICON’s sponsor-dedicated research model. Managing study teams, vendors, budgets, quality, and inspection readiness.

Responsibilities

  • Lead, provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities
  • Ensure clinical studies progress as planned and achieve milestones according to timelines, budget, and quality standards
  • Lead and facilitate communication across functions, external partners, and service providers
  • Lead and conduct investigator meetings and other study-related meetings
  • Provide input into and hold accountability for essential study-level documents from Clinical Study Protocol through Clinical Study Report
  • Develop and maintain study plans, quality and risk management plans, risk response strategies, and issue escalation pathways
  • Oversee external service providers, including CROs, central laboratories, IXRS, and ePRO vendors
  • Identify and report study quality issues and communicate corrective action plans
  • Oversee Trial Master File completion and ongoing quality-control activities
  • Ensure compliance with governance controls, including Delegation of Authority, Sunshine Act, financial attestations, and Clinical Trial Transparency
  • Re-forecast and manage study budgets and provide budget progress reports and mitigation plans
  • Ensure studies remain inspection-ready under ICH-GCP, SOPs, and relevant policies and serve as primary Study Management contact during audits or inspections
  • Provide performance feedback and mentor less experienced colleagues

Requirements

  • University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
  • 5+ years of relevant clinical experience in the pharmaceutical industry focused in Clinical Project/Trial Management
  • Experience overseeing large global clinical trial projects
  • Experience overseeing Oncology studies/projects is required
  • Legal right to work in the country where the role is based

Benefits

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Job title

Job type

Full Time

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Tech skills

Google Cloud Platform

Location requirements

RemoteUnited States

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