Global Study Director: Cross-Functional Lead for Trials

IQVIA LLC; Barcelona; Presencial; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a Global Study Associate Director to lead a cross-functional study team and oversee outsourced delivery for clinical studies in line with timelines, budget, and quality standards.

The role requires ICH-GCP knowledge, strong leadership, and experience in study management across all phases. You will drive planning, risk management, and stakeholder communication while ensuring inspection readiness and governance compliance.

Formación

• University degree (or equivalent) in medical or biological sciences or related field.
• 5 years of relevant clinical experience in pharma with 2 years’ PM experience or equivalent.
• Extensive knowledge of ICH-GCP and regulatory requirements.
• Strong project management and leadership abilities.

Responsabilidades

• Lead cross-functional study team and oversee outsourced delivery to meet milestones.
• Facilitate communication across functions and with external partners; conduct investigator meetings.
• Develop essential study documents (CSP to CSR) per SOPs.
• Ensure external providers meet goals and timelines; participate in vendor selection.
• Develop and maintain study quality and risk management plans; establish escalation paths.
• Ensure study information in systems (ACCORD/ABACUS, PharmaCM) is current and accurate.
• Monitor performance against plans and KPIs; report risks with mitigations to CPT and ds/DSM.
• Identify quality issues and implement CAPAs; communicate findings to stakeholders.
• Oversee TMF completion; ensure TMF plan and EDL; QC activities ongoing.
• Ensure governance controls compliance (Delegation of Authority, etc.).
• Budget re-forecasting and reporting; manage budget through lifecycle.
• Ensure inspection readiness; primary contact during audits.
• Provide performance feedback and mentoring; lead process-improvement projects.

Conocimientos

Project management

Team leadership

Communication

Strategic thinking

Problem solving

Educación

University degree in medical or biological sciences

Descripción del empleo

IQVIA is seeking a Global Study Associate Director to lead a cross-functional study team and oversee outsourced delivery for clinical studies in line with timelines, budget, and quality standards.

The role requires ICH-GCP knowledge, strong leadership, and experience in study management across all phases. You will drive planning, risk management, and stakeholder communication while ensuring inspection readiness and governance compliance.