Global Study Start-Up Lead — Regulatory & Activation

IQVIA; Warszawa; On-site; PLN 202,000 - 374,000; Full time

Job summary

IQVIA Biotech is seeking an experienced Study Start-Up Manager to lead site activation, regulatory and maintenance activities for global clinical studies. You will drive start-up strategies, timelines, budgets, and compliance across regions.

The role requires a Bachelor’s in Life Sciences, 7+ years in clinical research with international exposure, and strong knowledge of GCP/ICH. Leadership, negotiation, and cross-functional collaboration are essential in this dynamic environment.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Minimum 7 years of experience in clinical research, study start-up, regulatory affairs, or similar, including international experience.
• Strong knowledge of clinical trial regulations (GCP, ICH) and the drug development process.
• Proven experience managing multi-country start-up activities.
• Excellent leadership, stakeholder management, negotiation, communication and presentation skills.
• Strong financial, project management, and organizational capabilities.
• Demonstrated ability to manage multiple priorities in cross-functional teams.
• Proficiency with CTMS and other clinical research systems.

Responsibilities

• Lead global and regional site activation and regulatory activities from start-up through maintenance.
• Develop and execute study start-up strategies, project plans, and regulatory submission approaches to meet timelines.
• Oversee regulatory submissions, ethics approvals, essential documents, contracts, and site activation deliverables.
• Provide strategic guidance on regulatory requirements and country-specific challenges.
• Collaborate cross-functionally with project teams, sponsors, and regional stakeholders to drive study delivery.
• Monitor study progress, quality metrics, timelines, budgets, and resource utilization.
• Maintain accurate project information within CTMS and other tracking systems.
• Mentor and coach team members to promote operational excellence.
• Support business development activities including bid defenses, proposals, and client presentations.

Skills

Leadership

Stakeholder management

Negotiation

Communication

Presentation skills

Financial management

Project management

Organizational skills

Education

Bachelor's degree in Life Sciences

Tools

CTMS

Job description

IQVIA Biotech is seeking an experienced Study Start-Up Manager to lead site activation, regulatory and maintenance activities for global clinical studies. You will drive start-up strategies, timelines, budgets, and compliance across regions.

The role requires a Bachelor’s in Life Sciences, 7+ years in clinical research with international exposure, and strong knowledge of GCP/ICH. Leadership, negotiation, and cross-functional collaboration are essential in this dynamic environment.