Regulatory Start-Up Specialist 2

Responsibilities

• Perform country-level site activation activities in accordance with local and international regulations, SOPs, and project requirements.
• Serve as the Single Point of Contact (SPOC) for investigative sites, Site Activation Managers, and Project Management teams.
• Prepare, review, and distribute site regulatory documents, ensuring completeness and accuracy.
• Maintain internal systems, databases, and tracking tools with accurate project-specific information.
• Review and track the progress, approval, and execution of regulatory, ethics, and Informed Consent Form (ICF) documents.
• Provide local expertise to project teams during initial and ongoing timeline planning.
• Perform quality control on documents provided by clinical sites.

Requirements

• Bachelor's Degree in life sciences or a related field.
• 3 years of clinical research experience.
• 1 year of experience in a leadership capacity.
• In-depth knowledge of GCP/ICH guidelines and applicable regulatory requirements.
• Strong organizational, communication, and negotiating skills.
• Ability to manage multiple projects and work independently to prioritize tasks.
• Understanding of the regulated clinical trial environment and the drug development process.

About the Company

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.