Study Start Up Manager, IQVIA Biotech

IQVIA Argentina; Cataluña; Presencial; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

IQVIA, a global leader in clinical research services, seeks an experienced Senior Clinical Project Manager to oversee start-up, regulatory strategy, and multi-country trial activations. You will drive timelines, ensure regulatory compliance, and coordinate cross-functional teams across regions, with home-based flexibility in Spain.

You will mentor teams, optimize CTMS usage, and contribute to business development through proposals and client engagements.

Formación

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

Responsabilidades

• 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.

Conocimientos

Leadership

Regulatory affairs

GCP/ICH knowledge

Project management

Cross-country coordination

Stakeholder management

Communication

CTMS proficiency

Educación

Bachelor's degree in Life Sciences

Herramientas

CTMS

Descripción del empleo

Barcelona, Spain | Full time | Home-based | R1564053

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.

"I like that we're different. I like that we're a unique organization unlike any other. I like to think of us as the intelligence company for life sciences and healthcare. I do believe there's nothing else like this organization in the world. So if you like something that's different and interesting, you're going to like IQVIA. If you like an organization that has a variety of opportunities, from IT to big data to AI to finance to HR, there are so many opportunities to have an impact."

"The culture in IQVIA is to be constantly looking at how we can do things better to help our customers, to bring life-changing medicines to patients and also to be a part in designing and developing and implementing these solutions. And so I think it's a great place to join because there is that organizational focus and commitment in driving forward the innovation and just the ability, I think, to work with cross-functional teams who are all excited to be working in these areas. It's a fantastic opportunity."

"First of all, we are humans, we have some moments in our lives that are so very important and we need to respect. And something I also always love about IQVIA was that my leaders and people with which I have been working, they always respected a lot as well our personal lives. I never miss a parents' meeting of my kids, and this is something that we shouldn't be giving for granted."

Senior Director Global Site Activation

"I like that we're different. I like that we're a unique organization unlike any other. I like to think of us as the intelligence company for life sciences and healthcare. I do believe there's nothing else like this organization in the world. So if you like something that's different and interesting, you're going to like IQVIA. If you like an organization that has a variety of opportunities, from IT to big data to AI to finance to HR, there are so many opportunities to have an impact."

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.