- 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 systemRequirements- 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 regulatory requirements- Demonstrated abilities in clinical study management processes and clinical/drug development- Demonstrated solid project management skills and knowledge of relevant tools- Strong team leadership abilities- Ability to establish and maintain effective working relationships with internal and external co-workers and stakeholders- Strong conflict management skills- Excellent communication and interpersonal skills- Strong strategic and critical thinking abilities- Strong organizational and problem-solving skills- Ability to manage competing prioritiesCore CompetenciesDemonstrates extensive knowledge of ICH-GCP and clinical research regulatory requirements, along with strong project management skills to drive clinical study milestones while ensuring compliance and quality standards. Capable of leading cross-functional teams and managing external service providers to achieve study objectives.Highest-signal resume keywords- Clinical Study Management- Project Management- ICH-GCP Knowledge- Team Leadership- Risk ManagementHard Skills- Clinical Study Protocol Development- Budget Management- KPI Monitoring- Quality Control- Regulatory ComplianceSoft Skills- Excellent Communication- Conflict Management- Strategic Thinking- Organizational Skills- Problem-SolvingIndustry Keywords- Clinical Research- Pharmaceutical Industry- CRO Management- Study Plans- Audit ReadinessTools & Technologies- Trial Master File- Study Management Systems- Project Management Tools#J-18808-Ljbffr

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