Site Start Up Lead APAC

TL;DR

Site Start Up Lead APAC (Clinical Research): Execute site start-up strategy and planning for clinical trials, including document collection, ICF customization, IRB/EC and CA/MoH submissions, and delivery of IMP release packages with an accent on critical path planning, risk mitigations, and milestone oversight. Focus on collaborating with stakeholders, providing SME support, training staff, and ensuring timely site activation across APAC countries.

Location: Remote from Australia, China, Singapore, South Korea, or Taiwan; must be based in one of these countries

Company

Clinical Research Organization specializing in precision medicine, rare diseases, oncology, and other therapeutic areas with integrated clinical trial designs, operational expertise, and data analytics.

What you will do

• Manage site start-up process through activation readiness strategy, critical path planning, and oversight of delivery.
• Coordinate IRB/EC & CA/MoH strategy, ICF customization, risk mitigations, IMP release, and contract execution.
• Collaborate with stakeholders for milestone planning, client meetings, and alignment on operational goals.
• Partner with functional leaders to identify risks, execute mitigations, and maintain real-time tracking systems.
• Act as SME for site-level data, support translations, and communicate with key functions on status and deliverables.
• Develop country-specific summaries, facilitate training, mentor staff, and support proposal activities.

Requirements

• Based in Australia, China, Singapore, South Korea, or Taiwan
• Fluency in English and local language of the based country
• Bachelor's degree in life sciences or related field, or RN, or equivalent.
• 5+ years in start-up, ideally SU Lead or PM in CRO/pharma/biotech.
• 2+ years in project milestone management, resources, budgets, and team coordination.
• Demonstrated leadership in cross-functional activities, excellent communication and organizational skills.
• Experience with milestone tracking tools/systems and computerized systems.

Culture & Benefits

• Growing organization focused on groundbreaking cancer therapies and precision medicine.
• Employees' contributions appreciated, ideas valued, and input impacts positive change.
• Equal Opportunity Employer committed to diversity and inclusion.