Global Study Director: Cross-Functional Trial Lead

IQVIA; Argentina; On-site; ARS 1,800,000 - 2,600,000; Full time

Job summary

IQVIA in Argentina seeks a Global Study Associate Director (GSAD) to lead cross-functional study teams, ensure delivery of clinical studies on time and within budget, and serve as primary liaison between study team and Clinical Program Team. You will drive study planning, vendor oversight, TMF completeness, risk management, and inspection readiness while mentoring team members.

Your experience in ICH-GCP, project leadership, and collaboration with external partners will contribute to

Qualifications

• University degree in medical or biological sciences (or related field).
• 5 years of relevant clinical experience in pharma with 2 years in project management.
• Extensive knowledge of ICH-GCP and clinical regulatory requirements.
• Solid project management skills and knowledge of relevant tools.
• Strong leadership, communication and interpersonal abilities.
• Ability to manage competing priorities and cross-functional collaboration.

Responsibilities

• Lead cross-functional study teams or oversee outsourced delivery to meet milestones within timelines, budget, and quality.
• Coordinate communication across functions and external partners; conduct investigator meetings.
• Contribute to development of essential study documents from CSP to CSR in line with SOPs.
• Oversee CROs/vendors to ensure performance, timelines and budgets are met.
• Develop and maintain study plans with quality and risk management considerations.
• Ensure information in all study systems is current and accurate.
• Monitor TMF completion and QC activities to ensure full TMF integrity.
• Ensure governance controls and readiness for inspections; act as primary contact during audits.
• Manage study budget forecasting and provide financial risk reports to CPT.
• Provide feedback on performance and mentor junior staff; participate in process improvements.
• May act as SME for a process or system within Study Management.

Skills

Team leadership

Communication

Interpersonal skills

Strategic thinking

Problem-solving

Organizational skills

Education

University degree in medical or biological sciences

Tools

ACCORD/ABACUS

PharmaCM

Job description

IQVIA in Argentina seeks a Global Study Associate Director (GSAD) to lead cross-functional study teams, ensure delivery of clinical studies on time and within budget, and serve as primary liaison between study team and Clinical Program Team. You will drive study planning, vendor oversight, TMF completeness, risk management, and inspection readiness while mentoring team members.

Your experience in ICH-GCP, project leadership, and collaboration with external partners will contribute to