Global Study Start-Up Lead

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

Job summary

IQVIA Biotech is seeking a Study Start-Up Manager to lead activation, regulatory, and maintenance activities for global clinical studies. You will drive start-up strategies, timelines, budgets, and regulatory submissions, coordinating with cross-functional teams to ensure quality and compliance.

You will oversee essential documents, ethics approvals, contracts, and site activation deliverables while mentoring the team and supporting business development initiatives.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Minimum 7 years of experience in clinical research, study start-up, regulatory affairs, or related scientific environment, including international experience.
• Strong knowledge of clinical trial regulations, GCP, ICH guidelines, and drug development process.
• Proven experience managing complex, multi-country clinical trial 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 and deliver results through cross-functional teams.
• Proficiency with CTMS and other clinical research systems and technologies.

Responsibilities

• Lead global and regional site activation and regulatory activities from study start-up through maintenance phases.
• Develop and execute study start-up strategies, project plans, and regulatory submission approaches to achieve study timelines.
• Oversee regulatory submissions, ethics approvals, essential documents, contracts, and site activation deliverables.
• Provide strategic guidance on regulatory requirements, country-specific challenges, and risk mitigation solutions.
• Collaborate cross-functionally with project teams, sponsors, and regional stakeholders to drive successful 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, promoting operational excellence and knowledge sharing.
• Support business development activities, including bid defenses, proposals, and client presentations.

Skills

Leadership

Stakeholder management

Negotiation

Communication

Presentation

Project management

Regulatory knowledge

Cross-country collaboration

Education

Bachelor's degree in Life Sciences

Tools

CTMS

Job description

IQVIA Biotech is seeking a Study Start-Up Manager to lead activation, regulatory, and maintenance activities for global clinical studies. You will drive start-up strategies, timelines, budgets, and regulatory submissions, coordinating with cross-functional teams to ensure quality and compliance.

You will oversee essential documents, ethics approvals, contracts, and site activation deliverables while mentoring the team and supporting business development initiatives.