Study Startup Specialist II

We are looking for a motivated clinical research professional to join our team and support the successful start-up of clinical studies in Taiwan. In this role, you will work closely with project teams and investigational sites, coordinating activities from site contracts and regulatory documentation through to site activation. This is a great opportunity for someone with clinical start-up experience who enjoys working across multiple stakeholders, taking ownership of timelines, and helping studies move efficiently from planning to execution.

You will:

• Maintains study-specific and corporate startup tracking systems
• Facilitates site budgets and contract negotiations
• Supports site regulatory document collection
• Under supervision, may prepare initial submission dossiers to competent authorities, ethics committees, and/or site submission dossiers (as applicable)
• Communicates with the project team and investigational sites throughout the study startup phase
• Develops site specific startup timelines and enrollment projections and is responsible for meeting the site activation milestones
• May review study specific translations
• Supervises Trial Master File (TMF) maintenance throughout the study startup phase

• College/University degree in Life Sciences or an equivalent combination of education, training and experience
• 2-3 years prior clinical study and site startup experience
• Well-developed communication and organizational skills
• Ability to negotiate and build relationships at all levels
• Leadership, mentoring, and organizational skills

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.