Global Study Delivery Lead

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

Job summary

IQVIA LLC, a leading global provider of clinical research services, seeks a Global Study Associate Director (GSAD) to lead cross-functional study teams and oversee delivery to meet timelines, budget, and quality standards. The role interfaces with the Clinical Program Team and CPT, ensuring effective partnerships and inspections readiness.

The GSAD will drive study plans, risk management, TMF integrity, and governance adherence while mentoring staff and coordinating with external partners and

Qualifications

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
• 5 years of relevant clinical experience in the pharmaceutical industry, including 2 years’ project management experience, or equivalent combination of education, training and experience.
• Extensive knowledge of ICH‑GCP, clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development.
• Demonstrated solid project management skills and knowledge of relevant tools.
• Strong, demonstrated abilities/skills in team leadership.
• Strong abilities in establishing and maintaining effective working relationships with internal and external co‑workers and stakeholders, along with strong conflict management skills.
• Excellent communication and interpersonal skills.
• Strong strategic and critical thinking abilities.
• Strong organizational and problem‑solving skills.
• Ability to manage competing priorities.

Responsibilities

• Lead, provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget and quality standards.
• Lead and facilitate communication across all functions, including external partners and service providers.
• Provide input into and hold accountability for the development of essential study level documents (i.e., CSP through CSR) in accordance with SOPs.
• Ensure all external service providers engaged at the study level are performing to contracted goals and timelines/budget with adequate oversight.
• Develop and maintain relevant study plans including input into quality and risk management planning.
• Accountable for ensuring that information in all systems used at study level is current and accurate.
• Oversee study level performance against plans, milestones and KPIs, and communicate risks with mitigations.
• Identify and report quality issues and coordinate CAPAs with stakeholders.
• Oversee TMF completion and QC activities to ensure TMF completeness.
• Ensure timely compliance with governance controls and budgets.
• Support study budget management and reporting to CPT.
• Ensure studies are inspection-ready and serve as primary contact during audits.
• Provide feedback on performance and mentor colleagues.
• Work on process improvements and may act as Subject Matter Expert.

Skills

Cross-functional leadership

Project management

Communication

Strategic thinking

Organizational skills

Problem-solving

Relationship building

Education

University degree

Job description

IQVIA LLC, a leading global provider of clinical research services, seeks a Global Study Associate Director (GSAD) to lead cross-functional study teams and oversee delivery to meet timelines, budget, and quality standards. The role interfaces with the Clinical Program Team and CPT, ensuring effective partnerships and inspections readiness.

The GSAD will drive study plans, risk management, TMF integrity, and governance adherence while mentoring staff and coordinating with external partners and