Site Activation Specialist Belgium

📋 Description

• • Serve as Site Activation Specialist for a single sponsor partnership in Belgium, managing end-to-end site activation processes at the country level with moderate oversight from the SSU Country Manager.
• • Ensure all country-level deliverables meet project requirements and applicable regulatory rules, tracking milestone progress in real time using the SSU tracking system and providing clear rationale for delays.
• • Monitor project financials, including contract hours and task allocations, and escalate any discrepancies promptly.
• • Review, comply with, and maintain up-to-date knowledge of Standard Operating Procedures (SOPs) and Work Instructions (WIs), ensuring timesheet compliance and accurate training records.
• • Support continuous improvement of Site Start-Up (SSU) components including submissions, essential document collection, and communication with Competent Authorities and Ethics Committees (ECs).
• • Ensure all required documentation is accurately submitted to the Trial Master File (TMF) in alignment with company SOPs and sponsor requirements.
• • Prepare and submit Central EC Applications, Local EC Applications, Regulatory Authority (RA) submissions, and other local regulatory approvals as mandated by Belgian law.
• • Manage ongoing submissions, amendments, periodic notifications, and safety notifications to central and local ECs and RAs in accordance with local regulatory requirements.
• • Act as liaison between investigational sites and functional leads to resolve start-up-related issues and facilitate smooth site activation.
• • Serve as Country Start-Up Advisor by maintaining up-to-date local regulatory intelligence on submissions, EC applications, data protection notifications, and import/export licenses, and contributing to central repository updates.
• • Provide guidance on local data protection requirements for documents such as Principal Investigator/Informed Consent forms and Confidential Disclosure Agreements when no dedicated legal advisor is present.
• • Contribute to the development of local SOPs, Work Instructions, and internal training materials on Belgian clinical trial regulations.
• • Support site selection by providing feasibility input to the Site Selection Lead and Project Manager/Sponsor Account Manager based on clinical trial requirements.
• • Assist the Sponsor Account Manager in negotiating country-specific contract and budget templates, producing site-specific contracts, and supporting contract execution through the Site Contracts Service Centre.
• • Perform quality control on executed Clinical Trial Agreements (CTAs), arrange archival of documents into repositories, and capture required metadata.
• • Work remotely from home with one weekly visit to the sponsor office in Wavre, Belgium.
• • Maintain fluency in Dutch, French, and English to effectively communicate with local authorities, sites, and internal teams.
• • Demonstrate strong organizational, problem-solving, and negotiating skills while managing multiple complex projects simultaneously.
• • Work independently and collaboratively within a global team structure, ensuring quality-driven outcomes across all assigned activities.