Regulatory and Site Start Up Specialist

📋 Description

• • The Regulatory and Site Start Up Specialist ensures timely and high-quality site activation readiness for clinical trials in assigned countries or sites, managing regulatory submissions and mitigating risks to support trial execution.
• • Day-to-day responsibilities include preparing Clinical Trial Application Forms and submission dossiers for Competent Authorities and Ethics Committees, interacting with regulatory bodies, maintaining project plans and trackers, customizing patient information and consent forms, managing essential document collection for site activation, and coordinating with cross-functional teams such as Clinical Operations, Project Management, and Site Contracts.
• • Precision Medicine Group is a Clinical Research Organization specializing in precision medicine, with expertise in rare diseases, oncology, and other therapeutic areas, integrating clinical trial design, operational excellence, biomarker analytics, and medical expertise to advance client research.
• • The role offers deep exposure to global clinical trial regulations, site start-up processes, and regulatory intelligence, enabling the candidate to develop subject-matter expertise in regulatory affairs and site activation while contributing to groundbreaking cancer therapy research.