Medicine moves forward here. Ergomedis a specialist clinical research organization focused on rarediseaseand select oncology indications. The Specialist, Study Start Up and Regulatory Affairs leads and coordinates all activities related
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 mediumcomplexity, ensuring delivery in line with timelines, quality standards, and regulatoryrequirements.
Leads preparation, review, and quality control of regulatory and study start-updocumentation (including submissions, essential documents, and translations) to ensurecompleteness, 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 withproject requirements and country regulations and within the projected delivery timelines
Review all relevant documentation e.g. labels, patient information sheets, diary cards,insurance etc, to ensure compliance with ICH GCP & country specific requirements.
Promptly identify and elevate risk/potential risk to the project team which may jeopardisedeliverables; Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience
You’lljoin 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 (España)
🏢 Ergomed
📍 España