Regulatory and Site Start Up Specialist

📋 Description

• • The Regulatory and Site Start Up Specialist ensures timely and high-quality site activation readiness within assigned countries, mitigating risks and supporting clinical trial execution through regulatory compliance and operational excellence.
• • Day-to-day responsibilities include preparing and submitting clinical trial applications to Competent Authorities and Ethics Committees, reviewing and adapting Informed Consent Forms, managing essential documents, coordinating translations, maintaining project trackers, and acting as a Subject Matter Expert for site start-up activities.
• • Precision Medicine Group integrates clinical trial execution with scientific expertise, laboratory capabilities, and advanced data sciences to accelerate life-changing therapies, with a strong focus on Oncology and Rare Disease.
• • The role offers opportunities to deepen regulatory knowledge, lead country-specific compliance initiatives, mentor peers, and contribute to process improvements and tool development in a growing global CRO environment.