Global Study Associate Director (GSAD)

Location: Flexible/Remote
 

Our client is seeking an experienced Global Study Associate Director (GSAD) to lead the delivery of global clinical studies within a fast-paced drug development environment. This is a high-impact role responsible for overseeing cross-functional study teams and ensuring studies are delivered on time, within budget, and to the highest quality standards.

Key Responsibilities

• Lead and coordinate global cross-functional study teams to successfully deliver clinical studies.
• Drive study timelines, quality, budget management, and milestone achievement.
• Act as the primary point of contact between study teams, programme teams, CROs, and external vendors.
• Oversee outsourced study activities and ensure appropriate vendor oversight is maintained.
• Lead study planning, risk management, issue resolution, and escalation activities.
• Monitor study performance using project management and reporting tools, identifying risks and implementing mitigation plans.
• Ensure Trial Master File (TMF) completeness and inspection readiness throughout the study lifecycle.
• Manage study budgets, forecasting, and financial reporting.
• Support audits and regulatory inspections as the study operations lead.
• Contribute to process improvements and provide mentorship to less experienced colleagues.

Requirements

• Degree in Life Sciences, Clinical Research, or a related discipline.
• Minimum 7 years' clinical research experience within the pharmaceutical or biotechnology industry.
• At least 2 years' project management experience leading global clinical studies.
• Strong understanding of ICH-GCP, clinical trial regulations, and study management processes.
• Proven experience managing studies across the full clinical trial lifecycle.
• Demonstrated leadership skills with the ability to influence and manage cross-functional teams.
• Excellent stakeholder management, communication, problem-solving, and organisational skills.
• Experience managing study budgets, timelines, vendors, and risk mitigation activities.
• Proficiency with clinical trial management systems and project management tools.

Preferred Qualifications

• Advanced degree (Master's or higher).
• Formal Project Management certification.
• Extensive global study management experience across multiple phases of clinical development.

This is an excellent opportunity to join a leading organisation and play a pivotal role in the successful delivery of global clinical development programmes.