- 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 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 priorities

Core Competencies

Demonstrates 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 Management

Hard Skills

- Clinical Study Protocol Development
- Budget Management
- KPI Monitoring
- Quality Control
- Regulatory Compliance

Soft Skills

- Excellent Communication
- Conflict Management
- Strategic Thinking
- Organizational Skills
- Problem-Solving

Industry Keywords

- Clinical Research
- Pharmaceutical Industry
- CRO Management
- Study Plans
- Audit Readiness

Tools & Technologies

- Trial Master File
- Study Management Systems
- Project Management Tools

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