FSP Regulatory & StartUp Specialist

Help Bring Innovative Therapies to Patients Faster

At IQVIA, we are dedicated to advancing healthcare through clinical research, technology, and data-driven insights. Every study we support contributes to the development of new treatments that improve the lives of patients worldwide.

We are looking for a Site Activation Specialist to join our team in Colombia. This role is ideal for a clinical research professional with strong regulatory and study start-up experience who enjoys working in a fast-paced, collaborative, and international environment.

As a Site Activation Specialist, you will play a critical role in the successful activation of clinical trial sites, ensuring all regulatory and ethical requirements are completed efficiently and in compliance with local and international standards.

What You'll Do

As a key member of the Site Activation team, you will be responsible for managing and coordinating study start-up and regulatory activities from site selection through activation.

Key Responsibilities

• Serve as the primary point of contact for investigative sites during study start-up and site activation activities.
• Prepare, review, submit, and track regulatory documentation required for clinical trial activation.
• Coordinate submissions to Ethics Committees, Institutional Review Boards (IRBs), and local regulatory authorities, including interactions with the Ministry of Health when applicable.
• Develop and manage site-specific regulatory start-up packages and ensure timely completion of all required documentation.
• Oversee the preparation, review, tracking, and maintenance of Informed Consent Forms (ICFs) and other essential regulatory documents.
• Monitor the progress of regulatory submissions, approvals, and site activation milestones to ensure project timelines are met.
• Collaborate closely with Site Activation Managers, Project Managers, CRAs, and cross-functional teams to support study delivery.
• Maintain accurate records in internal databases, tracking systems, and project management tools.
• Perform quality reviews of site documentation to ensure compliance with applicable regulations, SOPs, and sponsor requirements.
• Identify potential start-up risks and proactively implement solutions to support study timelines.
• Provide country-specific regulatory expertise and support to global project teams.

What We're Looking For

Required Qualifications

• Bachelor's degree in Life Sciences or a related healthcare field.
• Minimum of 2 years of experience in Clinical Research, with a strong focus on regulatory affairs and study start-up activities.
• Proven experience with:
  • Ethics Committee and regulatory submissions.
  • Preparation and management of initial regulatory packages.
  • Informed Consent Form (ICF) development, review, and management.
  • Communication and coordination with health authorities, including the Ministry of Health and/or local regulatory agencies.
• Strong understanding of GCP, ICH guidelines, and local clinical research regulations.
• Fluent conversational English (spoken and written) is required.
• Excellent organizational skills and ability to manage multiple priorities simultaneously.
• Strong attention to detail and problem-solving capabilities.
• Ability to work independently while collaborating effectively with local and global teams.

Why IQVIA?

At IQVIA, you'll be part of a global organization that is transforming healthcare through innovation and clinical research. You'll have the opportunity to work on impactful studies, collaborate with international teams, and continue developing your career in an environment that values growth, inclusion, and professional excellence.

Join IQVIA and help accelerate the future of healthcare. 🚀

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.