Global Study Associate Director – Single Sponsor Dedicated

About the role

The Global Study Associate Director (GSAD) is a senior position within Study Management, responsible for delivering clinical studies on time, within budget and to quality standards. The GSAD leads cross‑functional teams, acts as the main liaison with the Clinical Program Team, and ensures compliance with regulatory and SOP requirements.

Key responsibilities

• Lead and guide cross‑functional study teams or outsourced partners to achieve milestones, timelines, budget and quality targets.
• Facilitate communication across all functions, conduct investigator and study meetings, and oversee external service providers such as CROs and laboratories.
• Develop and maintain study documents from protocol to final report, and ensure accurate, up‑to‑date information in study systems (e.g., ACCORD/ABACUS, PharmaCM).
• Manage study budgets, re‑forecasting and reporting financial risks, and ensure studies are inspection‑ready.

Required profile

• University degree in medical, biological sciences or related field.
• At least 5 years of clinical experience in pharma, including 2 years of project management.
• Strong knowledge of ICH‑GCP, clinical research regulations and study management processes.
• Proven leadership, communication and conflict‑management abilities.

Required skills

• ICH‑GCP and clinical research regulatory expertise.
• Project management tools and methodologies (e.g., risk‑based quality management, budget tracking).
• Use of study management systems such as ACCORD/ABACUS and PharmaCM.