Global Study Director, Clinical Operations

IQVIA; Województwo mazowieckie; On-site; PLN 300,000 - 540,000; Full time

Job summary

IQVIA is seeking a Global Study Associate Director (GSAD) to lead study management for clinical trials within BioPharmaceuticals. You will guide cross-functional teams, oversee outsourced delivery, and ensure milestones are met on time and within budget while maintaining quality across the study lifecycle.

The role requires strong leadership, strategic thinking, and a deep knowledge of ICH-GCP regulatory requirements.

Qualifications

• 5 years of relevant clinical experience in the pharmaceutical industry, including 2 years’ project management experience
• Extensive knowledge of ICH-GCP and clinical research regulatory requirements
• Strong leadership and communication abilities
• Ability to manage competing priorities and stakeholder relationships

Responsibilities

• Lead cross-functional study teams and oversee outsourced delivery to ensure progression against milestones
• Coordinate communications across functions and with external partners; lead investigator meetings
• Develop and maintain essential study documents (CSP through CSR) per SOPs
• Ensure external service providers meet contracted goals and escalate issues
• Oversee TMF completion and ensure timely QC activities for TMF completeness
• Manage study budget re-forecasting and provide budget reports to CPT with risks and mitigations
• Maintain inspection readiness and serve as primary Study Management contact during audits or inspections
• Provide feedback on performance and mentor junior colleagues
• Contribute to process improvements and lead non-drug project work as discussed with management
• May act as Subject Matter Expert for a process or system within Study Management

Skills

Leadership

Communication

Project management

Strategic thinking

Problem-solving

Team collaboration

Relationship management

Education

University degree in medical/biological sciences

Tools

Project management tools

Job description

IQVIA is seeking a Global Study Associate Director (GSAD) to lead study management for clinical trials within BioPharmaceuticals. You will guide cross-functional teams, oversee outsourced delivery, and ensure milestones are met on time and within budget while maintaining quality across the study lifecycle.

The role requires strong leadership, strategic thinking, and a deep knowledge of ICH-GCP regulatory requirements.