Global Study Lead, Clinical Operations

IQVIA Argentina; Warszawa; On-site; PLN 226,000 - 419,000; Full time

Job summary

IQVIA is seeking a Global Study Associate Director to lead cross-functional study teams and ensure delivery of clinical trials in line with timelines, budget and quality standards. The role is the main liaison with the Clinical Program Team and oversees external partners while ensuring inspection readiness and compliant governance.

The candidate will manage study budgets, participate in risk management, and provide mentorship to junior colleagues within Study Management.

Qualifications

• University degree (or equivalent) in medical or biological sciences.
• Minimum 5 years of relevant clinical experience in pharma with 2 years in project management.
• Extensive knowledge of ICH-GCP and regulatory requirements.
• Strong project management and leadership abilities.
• Ability to manage competing priorities and communicate with stakeholders.

Responsibilities

• Lead cross-functional study teams to deliver trials on time, budget, and quality.
• Facilitate communication across functions and with external partners.
• Develop essential study documents from CSP to CSR under SOPs.
• Oversee CROs, labs, IXRS, and ePRO to ensure contracted performance.
• Develop risk management plans and monitor quality metrics.
• Ensure TMF completeness and inspection readiness.

Skills

Project management

Cross-functional leadership

ICH-GCP knowledge

Clinical study management

Communication skills

Team leadership

Budget management

Regulatory requirements

Strategic thinking

Problem-solving

Education

University degree in medical or biological sciences

Tools

ACCORD/ABACUS

PharmaCM

IXRS

ePRO

Job description

IQVIA is seeking a Global Study Associate Director to lead cross-functional study teams and ensure delivery of clinical trials in line with timelines, budget and quality standards. The role is the main liaison with the Clinical Program Team and oversees external partners while ensuring inspection readiness and compliant governance.

The candidate will manage study budgets, participate in risk management, and provide mentorship to junior colleagues within Study Management.