Regulatory and Site Start Up Specialist

Precision for Medicine is seeking a Regulatory and Site Start Up Specialist to join their team remotely. This role involves managing regulatory and site start-up activities, including the preparation and submission of clinical trial applications to relevant authorities and ethics committees. The specialist will review informed consent forms, collect essential documents, and assist sites with submissions while also supporting the Site Contract Management group in budget and contract negotiations. The position requires an experienced professional who can act as a Subject Matter Expert for in-country team members and contribute to the development of compliance tools and guidance documents. Key responsibilities include ensuring timely and high-quality site activation readiness and identifying potential risks. While the advert does not specify required qualifications, it implies that significant experience in regulatory processes is essential. The role is suited for individuals with a strong background in clinical trials, particularly in oncology and rare diseases, who are adept at navigating local and international regulations. This position is fully remote, allowing for flexibility in work arrangements.