Study Start Up Manager, IQVIA Biotech

Barcelona, Spain | Full time | Home-based | 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.

Where you'll work

Home-based

You’ll work remotely, with the flexibility to do your best work from home. Supported by collaborative tools and a global team, you’ll stay connected while enjoying the autonomy and balance that comes with a fully remote role.

Culture

Culture at IQVIA is built on a shared belief: that when people are empowered with better data, smarter technology and deeper expertise, they can change what’s possible for patients. Across every team and every corner of the globe, you’ll find colleagues who genuinely care - about the mission and about each other. That’s what makes this a place where people tend to stay, grow and do the best work of their careers.