Study Startup Specialist I

Company Description

PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.

At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.

We offer an inspiring story of the company that has grown organically from a handful of countries to global presence.  PSI is a mature company with standards and practices, but we do not stand still.  Every day, there is a figurative Everest to climb, and you will not get bored here.

Job Description

Are you ready to play a key role in getting clinical trials off the ground?

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: 

• Maintain study-specific and corporate startup tracking systems
• Facilitate site budgets and contract negotiations
• Support site regulatory document collection
• Under supervision, may prepare initial/amendment submission dossiers to ethics committees, and/or site submission dossiers (as applicable)
• Communicates with the project team and investigational sites throughout the study lifecycle
• Develop site specific startup timelines and enrollment projections and is responsible for meeting the site activation milestones
• May review study specific translations
• Responsible for maintaining the Trial Master File (TMF) for assigned tasks throughout the study lifecycle

Qualifications

• Minimum of 1 years of experience in clinical development including start up process experience
• Bachelor’s degree or above, preferred in pharmaceutical/healthcare related majors
• Excellent communication skills, both written and verbal
• Full working proficiency in English and Chinese
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook)

Additional Information

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.