Global Oncology Study Lead — Phase III & Multiregional

IQVIA Argentina; Chicago (IL); Ibrido; USD 93.000 - 233.000; Tempo pieno

Descrizione del lavoro

IQVIA Biotech is seeking a Global Study Manager to drive end-to-end site management for multi-regional clinical trials. You will lead site identification, activation, monitoring oversight, and closeout, ensuring compliance with ICH-GCP and regulatory standards.

You will serve as the primary client contact, coordinate cross-functional teams across regions, and manage timelines, budget, and quality. This role requires 5+ years of global clinical research/monitoring experience, including 2 years in

Competenze

• Bachelor’s degree in life sciences or related field required.
• 5+ years of clinical research/monitoring experience, including 2 years in a clinical study management role.
• Strong knowledge of ICH-GCP, FDA regulations, and clinical trial processes.
• Experience managing global clinical trials and multi-regional teams.
• Demonstrated experience in project financial management.

Mansioni

• Lead site management strategy from study award through close-out.
• Oversee site identification, selection, activation, and recruitment performance.
• Ensure clinical monitoring processes meet study needs and timelines.
• Partner with CRAs to optimize enrollment, data quality, and compliance.
• Serve as primary client contact and own key customer relationships.
• Lead cross-functional teams across regions and cultures.
• Facilitate internal and external meetings, including executive presentations.
• Drive collaboration across stakeholders, vendors, and functional leads.
• Develop and manage integrated study plans and risk mitigation strategies.
• Proactively identify risks and implement corrective/preventative actions.
• Monitor study timelines, enrollment trends, and data quality metrics.
• Ensure compliance with GCP, SOPs, protocols, and regulatory standards.
• Manage study financials, including forecasting and revenue acceleration.
• Identify and manage out-of-scope work and change orders.
• Oversee BURs and expense approvals.
• Track performance against budget and EAC.
• Maintain TMF health and ensure timely document submission.
• Develop quality monitoring plans and compliance metrics.
• Ensure adherence to study tools, training materials, and processes.
• Lead and mentor cross-functional project teams.
• Support CRA and team training on therapeutic areas and study-specific needs.
• Foster collaboration, knowledge sharing, and continuous improvement.

Conoscenze

Global study management

Multi-regional experience

Phase I-III experience

Oncology experience

Therapeutic area breadth

Formazione

Bachelor’s degree in life sciences or related field

Descrizione del lavoro

IQVIA Biotech is seeking a Global Study Manager to drive end-to-end site management for multi-regional clinical trials. You will lead site identification, activation, monitoring oversight, and closeout, ensuring compliance with ICH-GCP and regulatory standards.

You will serve as the primary client contact, coordinate cross-functional teams across regions, and manage timelines, budget, and quality. This role requires 5+ years of global clinical research/monitoring experience, including 2 years in