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

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