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Global Study Lead

Roche
8+ years
preferred by company
Multiple, Locations
1 May 14, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences, Clinical Research, Clinical Trials, Curious Mindset, Databases, Drug Development, Job Description, Lifesciences, Medical Communication, Medical Information, Medical Writing, Military Intelligence, Pat

Global Study Lead

Company: Roche
Category: Research & Development
Job ID: 202605-111498
Employment Type: Full-time
Location: Multiple Locations

Job Overview

The Global Study Lead is responsible for end-to-end management of global clinical studies, ensuring studies are designed, planned, executed, monitored, and closed within timeline, budget, quality, and regulatory compliance requirements.

Key Responsibilities

  • Lead global study teams with accountability for quality, timelines, and budget.
  • Design and execute sponsored clinical studies.
  • Develop study strategies for evidence generation, including real-world evidence.
  • Create study documents such as protocols, validation plans, reports, forms, and training materials.
  • Manage companion diagnostics studies with Pharma partners.
  • Handle study budget planning and execution.
  • Ensure compliance with regulatory guidelines, SOPs, and audit readiness.
  • Oversee CROs, consultants, medical advisors, and outsourced study operations.
  • Track project timelines, scope, deliverables, and performance.
  • Coordinate study execution across planning, startup, conduct, and closeout phases.
  • Support study result publication with publication teams.
  • Collaborate with Regulatory Affairs, R&D, Clinical teams, and external stakeholders.

Required Skills

  • Clinical study management
  • Global trial execution
  • Study design
  • Budget management
  • Timeline planning
  • Regulatory compliance
  • GCP / SOP compliance
  • CRO/vendor management
  • Companion diagnostics
  • Clinical documentation
  • Protocol development
  • Risk management
  • Audit/inspection readiness
  • Cross-functional collaboration
  • Stakeholder management
  • Project management

Preferred Background

  • Clinical research
  • Clinical operations
  • Biotechnology
  • Pharma R&D
  • Diagnostics
  • Companion diagnostics