Regulatory & Site Activation Specialist

🕒 4 days ago

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IQVIA

WebsiteLinkedInAll Job Openings

10,000+ employees

⚕️ Healthcare Insurance

🧬 Biotechnology

🤖 Artificial Intelligence

💰 $1G Post-IPO Debt on 2023-05

Healthcare Insurance • Biotechnology • Artificial Intelligence

IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients.

📋 Description

• Act as the primary point of contact for investigative sites in Poland, ensuring clear and proactive communication • Lead and manage country-level regulatory and start-up activities, including site activation processes • Prepare, review, and submit EU CTR (Part II) applications via CTIS, ensuring compliance with Polish regulations • Perform and manage country-specific ICF adaptations, including review, localization, and alignment with protocol and regulatory requirements • Coordinate and execute Essential Document Package (EDP) activities, including: Collection, review, and tracking of essential documents; Quality control (QC) of site and regulatory documents; Ensuring completeness and readiness for regulatory green light • Manage communication with sites to support document collection, submissions, and activation timelines • Liaise with Ethics Committees, Competent Authorities, and internal stakeholders to facilitate approvals • Support responses to RFIs (Requests for Information) and manage submission follow-ups • Maintain and update CTMS, TMF, and tracking systems with accurate and timely information • Review and ensure readiness of site activation packages / Green Light Packages • Track and report site activation progress, timelines, and KPIs • Ensure all activities are performed in compliance with ICH-GCP, EU CTR, and Polish regulatory requirements

🎯 Requirements

• Based in Poland with strong knowledge of the local regulatory environment • Bachelor’s degree in Life Sciences or related field • Polish language fluency (required) and strong English skills (written and spoken) • 2–4+ years of experience in Regulatory Affairs, Study Start-Up, or Site Activation • Experience working in a local Polish regulatory role within a CRO or sponsor • Proven experience with: EU CTR submissions (Part II) in Poland, Country-level ICF adaptations, Essential Document Package (EDP) / activation package management, CTIS system usage, Regulatory green light / site readiness processes • Strong understanding of clinical trial start-up workflows and regulatory timelines • Experience interacting with sites, Ethics Committees, and regulatory authorities • Ability to manage multiple sites and competing timelines effectively • High attention to detail, strong organizational skills, and a proactive working style.