Global Study Delivery Director

IQVIA; Madrid; Presencial; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a Global Study Associate Director to lead cross-functional study teams within Clinical Operations. This role oversees timelines, budget and quality, partnering with CPT and external vendors to drive successful study delivery from handover to close-out.

The GSAD ensures regulatory compliance, quality standards and effective communication across all functions, mentors staff, and supports process improvements across study management activities.

Formación

• University degree in a medical/biological sciences field or related clinical research discipline.
• 5 years of relevant clinical experience in pharma, including 2 years in project management or an equivalent combination of education and experience.

Responsabilidades

• Lead cross-functional study teams to deliver milestones on time within budget and quality standards.
• Facilitate communication across all functions and with external partners; lead investigator meetings.
• Contribute to development of essential study documents from CSP to CSR per SOPs.
• Oversee external service providers (CROs, labs, IXRS, ePRO) to meet goals; participate in vendor selection.
• Develop and maintain study plans including quality and risk management; define risk mitigation strategies.
• Ensure information in study systems (ACCORD/ABACUS, PharmaCM) is current and accurate.
• Monitor study performance against plans and KPIs; report risks with mitigations to CPT and DSM.
• Identify and report quality issues; coordinate CAPAs with stakeholders.
• Oversee TMF completion; ensure TMF plan and EDL exist and QC is ongoing.
• Ensure governance controls (DAO, Sunshine Act, financial attestations) are complied with.
• Budget re-forecasting and management; provide budget progress reports to CPT with risks.
• Maintain inspection-readiness; act as primary contact during audits/inspections.
• Provide feedback and mentoring to team members; support professional development.
• Contribute to non-drug project work and process improvement initiatives.

Conocimientos

Cross-functional leadership

Project management

Educación

University degree (medical/biological sciences or clinical research related)

Descripción del empleo

IQVIA is seeking a Global Study Associate Director to lead cross-functional study teams within Clinical Operations. This role oversees timelines, budget and quality, partnering with CPT and external vendors to drive successful study delivery from handover to close-out.

The GSAD ensures regulatory compliance, quality standards and effective communication across all functions, mentors staff, and supports process improvements across study management activities.