Company Description Medicine moves forward here.

Company Description Medicine moves forward here. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, data quality and the experience of sites and patients at the same time. The Specialist, Study Start Up and Regulatory Affairs leads and coordinates all activities related to achieving site initiation readiness.

The role provides subject matter expertise, ensures regulatory compliance, and serves as a key liaison between internal teams, clients, and external stakeholders. Leads study start-up and regulatory activities for assigned countries or projects of medium complexity, ensuring delivery in line with timelines, quality standards, and regulatory requirements. Leads preparation, review, and quality control of regulatory and study start-up documentation (including submissions, essential documents, and translations) to ensure completeness, accuracy, and compliance with ICH-GCP and country-specific requirements.

Responsible for drafting,



negotiating, finalizing, and executing clinical site agreements, ancillary agreements as well as amendments at country or regional level, in accordance with project requirements and country regulations and within the projected delivery timelines G. labels, patient information sheets, diary cards, insurance etc, to ensure compliance with ICH GCP & country specific requirements. Contribute towards the preparation and/or review of complex technical/scientific/legal documentation. Promptly identify and elevate risk/potential risk to the project team which may jeopardise deliverables; Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience You'll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

Quality: we hold ourselves to the standard patients deserve.

📌 Study Start Up And Regulatory Affairs Specialist (2 Years Plus Experience) (Madrid)
🏢 Ergomed
📍 Madrid