Site Activation Specialist

Iqvia; Bardi; In loco; EUR 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

IQVIA is seeking a site activation specialist to support feasibility, site identification, regulatory start-up and maintenance activities at regional levels. You will act as a single point of contact with Site Activation Manager and cross-functional teams to ensure documents, timelines and contracts are properly managed.

You will prepare and review site documentation, maintain project systems to track progress and compliance, coordinate regulatory and ethics submissions (ICF, CDAs) and support

Competenze

• Bachelor's degree in Life sciences or related field.
• 1–3 years’ clinical research or relevant experience.
• Regulatory and ethics documentation experience (ICF, CDAs, IP release).
• Strong attention to detail and documentation management.
• Cross-functional collaboration.
• Good communication.

Mansioni

• Serve as a single point of contact for feasibility, site activation, and some maintenance activities in assigned studies.
• Review site documents for completeness, consistency, and accuracy under supervision.
• Prepare and review site documentation and notify team upon completion.
• Distribute completed documents to sites and internal stakeholders.
• Maintain internal systems, databases, tracking tools, timelines, and project plans with accurate data.
• Track and follow up on progress, approvals, and execution of regulatory, ethics, CDAs, ICF, and IP release documents.
• Assist in updating contracts and ensuring full execution.
• Coordinate with SAM, Project Management, and other departments to support site activation at country/region level.
• Monitor and report on site performance metrics.
• Ensure adherence to local and international regulations and SOPs.

Conoscenze

Cross-functional collaboration

Attention to detail

Regulatory documentation management

Good communication

Contract review

Project tracking

Formazione

Bachelor's degree in Life sciences or related field

Descrizione del lavoro

In this role, you support feasibility, site identification, regulatory, start-up, and maintenance activities at regional or country levels. You work as a SPOC with the Site Activation Manager and cross-functional teams to ensure documents, timelines, and contracts are properly managed. You will prepare and review site documentation and maintain project systems to track progress and compliance. You contribute to site activation by coordinating regulatory, ethics, and ICF-related activities while upholding SOPs and contractual guidelines. This position offers exposure to a global clinical research environment that aims to improve patient outcomes and population health.

• Serve as a single point of contact for feasibility, site activation, and some maintenance activities in assigned studies
• Review site documents for completeness, consistency, and accuracy under supervision
• Prepare and review site documentation and notify team upon completion
• Distribute completed documents to sites and internal stakeholders
• Maintain internal systems, databases, tracking tools, timelines, and project plans with accurate data
• Track and follow up on progress, approvals, and execution of regulatory, ethics, CDAs, ICF, and IP release documents
• Assist in updating contracts and ensuring full execution
• Coordinate with SAM, Project Management, and other departments to support site activation at country/region level
• Monitor and report on site performance metrics
• Ensure adherence to local and international regulations and SOPs
• Bachelor's degree in Life sciences or related field
• 1–3 years’ clinical research or relevant experience
• Alternatively 3 years’ experience in a healthcare environment or equivalent
• Regulatory and ethics documentation experience (ICF, CDAs, IP release)
• Strong attention to detail and documentation management
• Cross-functional collaboration
• Good communication
• Regulatory documentation management
• Contract review and tracking
• Project tracking tools and databases