Lead and provide guidance to cross-functional study teams or oversee outsourced delivery activities
Drive clinical study milestones according to timelines, budget, and quality standards
Lead communication across functions, external partners, and service providers
Lead investigator meetings and other study-related meetings
Develop and provide input into essential study-level documents from the Clinical Study Protocol through the Clinical Study Report
Oversee external service providers, including CROs, central laboratories, IXRS, and ePRO providers
Develop and maintain study plans, quality and risk management plans, risk response strategies, and issue escalation pathways
Ensure study-level systems contain current and accurate information
Monitor study performance against plans, milestones, and KPIs and communicate risks and mitigations
Identify and report quality issues and coordinate 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 throughout the study lifecycle and report financial risks and mitigations
Ensure studies remain inspection-ready and act as the primary Study Management contact for audits or inspections
Provide performance feedback, support professional development, and mentor less experienced colleagues
Represent Study Management in process improvements and lead improvement projects
Act as a Subject Matter Expert for a Study Management process or system
Requirements University degree (or equivalent), preferably in medical or biological sciences or a discipline associated with clinical research
5 years of relevant clinical experience in the pharmaceutical industry
2 years of project management experience, or equivalent combination of education, training and experience
Extensive knowledge of ICH-GCP and clinical research re

📌 Global Study Associate Director – Single Sponsor (Madrid)
🏢 Jobtailor
📍 Madrid