Study Start-Up Lead: Site Activation & Regulatory

IQVIA Argentina; Buenos Aires; Presencial; ARS 3.000.000 - 5.200.000; Jornada completa

Descripción de la vacante

IQVIA is a leading global provider of clinical research services and healthcare insights. The role leads site activation and maintenance across studies, guiding regulatory strategies and execution for multi-protocol programs.

You will coordinate with cross-regional teams, ensure regulatory compliance, review documentation, and support business development while mentoring colleagues and managing timelines and budgets.

Formación

• Bachelor's degree in life sciences or a related field.
• 7 years of relevant experience in a scientific or clinical environment, including international roles.
• Strong negotiation and communication skills with ability to challenge.
• Excellent interpersonal skills and a strong team player.
• Proven ability to deliver results to quality and timeline metrics.
• Thorough understanding of regulated clinical trial environments and drug development.
• Proficiency with systems and technology to achieve work objectives.
• Good regulatory and/or technical writing skills.
• Solid knowledge of GCP and ICH guidelines and applicable regulatory guidelines.
• Leadership ability to motivate, coach and mentor others.
• Excellent organizational and planning skills.
• Ability to exercise independent judgment and manage multiple projects.

Responsabilidades

• Oversee the execution of Site Activation and Maintenance for assigned projects per RSU strategy.
• Develop, implement and maintain the Management Plan within the project strategy.
• Collaborate with Regulatory & Site Activation across regions to deliver scope in compliance.
• Provide regulatory and technical support to enable study initiation and maintenance.
• Guide multi-regional and multi-protocol programs as part of the study management team.
• Determine regulatory strategy and parameters for submissions and authorizations.
• Identify regulatory complexities and propose practical solutions for bid and execution phases.
• Ensure quality standards via Quality Management; maintain CTMS and tracking tools.
• Mentor colleagues and foster relationships with IQVIA customers.
• Deliver presentations and training to clients and professionals; assist in budget planning.

Conocimientos

Regulatory strategy

Project management

GCP/ICH knowledge

Regulatory writing

Leadership

Stakeholder management

Budget management

Communication skills

Cross-functional collaboration

Educación

Bachelor's Degree Life sciences or related field

Herramientas

CTMS

Regulatory databases

Descripción del empleo

IQVIA is a leading global provider of clinical research services and healthcare insights. The role leads site activation and maintenance across studies, guiding regulatory strategies and execution for multi-protocol programs.

You will coordinate with cross-regional teams, ensure regulatory compliance, review documentation, and support business development while mentoring colleagues and managing timelines and budgets.