Global Study Associate Director – Single Sponsor

About the role

The Global Study Associate Director (GSAD) leads cross‑functional study teams to deliver clinical studies on time, within budget and to quality standards. This senior position acts as the primary liaison between the study team and the Clinical Program Team from handover through close‑out.

Key responsibilities

• Lead and guide cross‑functional or outsourced study teams, ensuring milestones are met according to timelines, budget and quality standards.
• Facilitate communication across all functions and external partners, conduct investigator and study meetings.
• Oversee development of study documents from protocol to final report and ensure compliance with SOPs and ICH‑GCP.
• Manage external service providers (CROs, labs, IXRS, ePRO) to meet contractual goals and document oversight.
• Maintain study plans, risk‑based quality management, and ensure accurate information in systems such as ACCORD/ABACUS and PharmaCM.
• Monitor study performance against KPIs, report risks and propose mitigations to the CPT.
• Ensure trial master file completeness and readiness for inspections.
• Handle study budget forecasting, management and reporting throughout the study lifecycle.

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.
• Extensive knowledge of ICH‑GCP and clinical research regulations.
• Strong leadership, communication and conflict‑management abilities.
• Proven strategic, critical‑thinking and problem‑solving skills.

Required skills

• ICH‑GCP compliance
• Clinical study management tools (ACCORD/ABACUS, PharmaCM)
• Risk‑based quality management
• Budget forecasting and financial oversight
• Vendor oversight and CRO management