Study Start Up Manager, IQVIA Biotech

IQVIA; Barcelona; Presencial; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

IQVIA Biotech is seeking an experienced Study Start-Up Manager to lead site activation, regulatory submissions, and maintenance for global clinical studies. You will drive start-up strategies, manage timelines, budgets, and regulatory requirements while ensuring high-quality execution and compliance.

Responsibilities include overseeing submissions, ethics approvals, essential documents, contracts, and cross-functional collaboration with sponsors and regional teams.

Formación

• Bachelor's degree in Life Sciences or related field.
• 7+ years in clinical research, study start-up, regulatory affairs, or similar, with international exposure.
• Strong knowledge of clinical trial regulations, GCP/ICH, and drug development.
• Experience leading multi-country start-up activities and cross-functional teams.

Responsabilidades

• Lead global and regional site activation and regulatory activities from start-up through maintenance.
• Develop and execute start-up strategies, project plans, and regulatory submission approaches.
• Oversee regulatory submissions, ethics approvals, essential documents, contracts, and deliverables.
• Provide strategic guidance on regulatory requirements and risk mitigation.
• Collaborate with project teams, sponsors, and regional stakeholders to deliver studies.
• Monitor progress, quality metrics, timelines, budgets, and resources.
• Maintain project data in CTMS and other tracking systems.
• Mentor and coach team members to promote operational excellence.
• Support business development activities, including bid defenses and client presentations.

Conocimientos

Leadership

Stakeholder management

Negotiation

Communication

Presentation skills

Financial management

Project management

Organizational capabilities

CTMS proficiency

Cross-functional collaboration

Educación

Bachelor's degree in Life Sciences or related field

Herramientas

CTMS

Descripción del empleo

Bucuresti, Romania

Belgrade, Serbia

Lisbon, Portugal

Barcelona, Spain

Prague, Czech Republic

Full time

R1564053

Study Start-Up Manager

IQVIA Biotech

Job Overview

IQVIA Biotech is seeking an experienced Study Start-Up Manager to lead and oversee all site activation, regulatory, and maintenance activities for assigned clinical studies and programs. This role is accountable for delivering study start-up strategies, managing timelines, resources, budgets, and regulatory requirements, while ensuring high-quality execution and compliance across global clinical trials.

Key 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.

Qualifications & Experience

• Bachelor's degree in Life Sciences or a related field.

• Minimum 7 years of experience in clinical research, study start-up, regulatory affairs, or a related scientific environment, including international experience.

• Strong knowledge of clinical trial regulations, GCP, ICH guidelines, and the 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled