About the job
At Precision for Medicine, we are a premier Clinical Research Organization committed to advancing precision medicine. Our integrated approach harnesses innovative clinical trial designs, expert operational and medical teams, advanced biomarker analytics, and a deep passion for addressing rare diseases and oncology, among other therapeutic areas.
As we continue to expand, we are looking for a Site Start Up Lead to join our dynamic team. This position can be based in Australia, Singapore, South Korea, or Taiwan.
Position Overview:
The Site Start Up Lead is a key player in global site start-up activities, responsible for executing the site start-up strategy and ensuring meticulous planning and coordination. This includes managing document collections, customizing and approving informed consent forms (ICFs), handling submissions to Institutional Review Boards (IRB), Ethics Committees (EC), and Competent Authorities (CA), and delivering high-quality Investigational Medicinal Product (IMP) release packages. The incumbent will serve as a Subject Matter Expert and provide training to less experienced staff while managing country-specific tools and guidelines to facilitate knowledge sharing regarding site start-up operations.
Key Responsibilities:
• Oversee the site start-up process by developing a comprehensive activation readiness strategy.
• Coordinate and present critical path planning, including IRB/EC and CA submission strategies, ICF customization, risk mitigation plans, IMP release requirements, and contract execution.
• Collaborate closely with stakeholders to gather input for milestone planning and ensure alignment with operational goals for timely site activation.
• Engage in client meetings to clarify expectations related to delivery timelines, communication, risk mitigation strategies, status updates, and site start-up metrics.
• Work in partnership with Functional Leaders and Site Start-Up Specialists to proactively identify and address potential risks to delivery timelines.

