Global Study Associate Director – Single Sponsor

Jobtailor; Madrid; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Jobtailor in Madrid seeks a Senior Study Manager to lead cross-functional clinical study delivery, ensuring milestones, budget, and quality standards are met.

You will oversee CROs and service providers, develop study plans, and maintain compliance with governance and regulatory requirements while mentoring colleagues and driving process improvements.

Formación

• University degree (or equivalent) in medical or biological sciences or related field.
• 5 years of clinical experience in the pharmaceutical industry.
• 2 years of project management experience or equivalent.
• Extensive knowledge of ICH-GCP and clinical research regulatory requirements.
• Demonstrated abilities in clinical study management processes and clinical/drug development.
• 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 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.

Responsabilidades

• 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 governance compliance 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.

Conocimientos

Team leadership

Communication

Strategic thinking

Organizational skills

Problem-solving

Ability to manage priorities

Interpersonal skills

Conflict management

Stakeholder management

Educación

University degree in medical/biological sciences

Herramientas

Trial Master File

Study Management Systems

Project Management Tools

Descripción del empleo

• 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