Site Activation Specialist - Portugal

About the role

IQVIA's Global Site Activation team is looking for a Site Activation Specialist based in Portugal. As a single point of contact, you will carry out feasibility, site activation and some maintenance activities for assigned studies at investigative sites, in line with applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager, the Project Management team and other departments.

Key responsibilities

• Review documents for completeness, consistency and accuracy under the guidance of senior staff, and prepare site documents and notify team members of the completion of regulatory and contractual documents.
• Distribute completed documents to sites and internal project team members, and update and maintain internal systems, databases, tracking tools, timelines and project plans with accurate, complete project information.
• Review, track and follow up the progress, approval and execution of required documents such as questionnaires, CDAs, regulatory and ethics documents, Informed Consent Forms and Investigator Pack release documents.

Required profile

• Bachelor's degree in Life Sciences or a related field.
• At least 3 years of prior experience in clinical research.
• Experience with submissions to Ethics Committees and Regulatory Authorities, contract and budget negotiations, study start-up activities and overall site activation processes.
• Familiarity with the day-to-day responsibilities of Global Site Activation.
• Ability to work independently and to collaborate with others, with good interpersonal, communication and organisational skills.
• Ability to work on multiple projects.

Required skills

• Knowledge of applicable functional and regulatory requirements, including local regulations, SOPs and ICH/GCP.