Study Start Up Manager - IQVIA Biotech - Portugal

IQVIA; Oeiras; On-site; EUR 85,000 - 120,000; Full time

Job summary

IQVIA Biotech is seeking a Study Start Up Manager to lead strategic planning and execution of site activation across complex, global studies. You will partner with cross-functional teams and clients to ensure timely start-up, compliance, and high-quality delivery in a fast-paced, international environment.

You will provide regulatory guidance, manage project scope and budgets, and mentor colleagues while driving operational excellence and client success across programs.

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• Minimum 7 years in scientific, clinical research, regulatory affairs, or site activation.
• Experience in global/international clinical programs.
• Strong understanding of the clinical trial lifecycle and regulatory requirements.
• Expertise in GCP/ICH guidelines and regulatory frameworks.

Responsibilities

• Lead and oversee global site activation and maintenance activities for assigned studies and programs.
• Develop regulatory and site activation strategies to ensure timely study start-up and ongoing compliance.
• Collaborate with cross-functional study teams, sponsors, and regional stakeholders to hit milestones.
• Provide regulatory guidance to support business development, bid defense, and study execution.
• Manage project scope, timelines, budgets, resources, and quality throughout the lifecycle.
• Identify regulatory risks and develop solutions to accelerate study delivery.
• Oversee maintenance of study approvals, essential documents, contracts, and submissions.
• Mentor colleagues and promote operational excellence across teams.
• Build relationships with sponsors and stakeholders as a trusted SME.

Skills

Leadership

Project management

Regulatory affairs

Stakeholder management

GCP/ICH knowledge

Communication

Negotiation

Education

Bachelor's degree in Life Sciences

Tools

CTMS

Clinical databases

Job description

Study Start Up Manager

Are you a seasoned clinical research professional with a passion for regulatory strategy, site activation excellence, and leading high-performing teams? Join IQVIA Biotech and play a pivotal role in delivering innovative clinical trials that help bring life-changing therapies to patients worldwide.

As a Study Start Up Manager, you will lead the strategic planning and execution of site activation and maintenance activities across complex, global clinical studies and multi-protocol programs. This is an exciting opportunity for a collaborative leader who thrives in a fast-paced, international environment and is motivated by driving operational excellence and client success.

What You'll Be Doing

• Lead and oversee global site activation and maintenance activities for assigned clinical studies and programs.
• Develop and execute regulatory and site activation strategies that ensure timely study start-up and ongoing compliance.
• Partner closely with cross-functional study teams, clients, and country/regional stakeholders to achieve project milestones.
• Provide expert regulatory guidance and intelligence to support business development, bid defense activities, and study execution.
• Manage project scope, timelines, budgets, resources, and quality standards throughout the study lifecycle.
• Identify regulatory risks and challenges, developing innovative and practical solutions to accelerate study delivery.
• Oversee maintenance of clinical study approvals, essential documents, contracts, and regulatory submissions.
• Mentor and coach colleagues, fostering development and promoting operational excellence across teams.
• Build and maintain strong relationships with sponsors and key stakeholders while serving as a trusted subject matter expert.
  

What You'll Bring

Required Qualifications

• Bachelor's Degree in Life Sciences or a related discipline.
• Minimum of 7 years of experience within a scientific, clinical research, regulatory affairs, or site activation environment.
• Demonstrated experience working in global or international clinical research programs.
• Strong understanding of the clinical trial lifecycle, drug development process, and regulatory requirements.
• Expertise in Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and applicable regulatory frameworks.
• Proven leadership experience with the ability to motivate, mentor, and influence others.
• Excellent project management, organizational, and financial management skills.
• Strong negotiation, communication, presentation, and stakeholder management abilities.
• Ability to manage multiple priorities and deliver results within complex, fast-paced environments.
• Proficiency with clinical systems, databases, CTMS platforms, and project tracking tools.
  

Why Join IQVIA Biotech?

At IQVIA, you'll work alongside some of the industry's brightest minds, supporting groundbreaking research that improves patient outcomes worldwide.

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.

At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.