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Precision for Medicine, a Clinical Research Organization, is seeking a Site Start-Up Lead for the APAC region (Australia, Singapore, South Korea, Taiwan, China). This role is central to executing site activation strategies for clinical trials, with accountability for managing the entire start-up lifecycle including document collection, ICF customization, regulatory submissions (IRB/EC, CA/MoH), and IMP release coordination.
Key responsibilities include developing and presenting critical path plans, coordinating with cross-functional stakeholders (Feasibility, Clinical Operations, Regulatory, Site Contracts), identifying and mitigating delivery risks, and maintaining real-time tracking of progress metrics. The role requires acting as a subject matter expert for in-country teams, mentoring less-experienced staff on start-up procedures, and supporting client meetings to establish expectations around timelines and risk mitigation.
You will manage country-specific start-up processes, coordinate document translations, maintain IRB/Ethics Committee timelines and site contract data, and develop country-specific start-up summaries and process flows. The position involves direct support of country and site-level activities as needed, facilitation of training sessions, and interaction with clients during proposal activities.
Required qualifications: Bachelor's degree in life sciences or equivalent (or RN); 5+ years in clinical trial start-up (ideally with SU Lead or PM experience in a CRO or pharma/biotech setting); 2+ years managing project milestones, resources, and budgets. Demonstrated cross-functional leadership, excellent communication and organizational skills, proficiency with milestone tracking tools, and fluency in English plus the local language of your assigned country are essential.
