Study Startup Specialist I

Job Description

Take your career to the next level and lead challenging study activation process on a country level. You will support clinical research teams and ensure PSI projects start smoothly and on time. 

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 and amendment submission dossiers to competent authorities, ethics committees, and/or site submission dossiers (as applicable).
• Communicates with the project team and investigational sites throughout the entire duration of the study.
• Develops site specific startup timelines 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.

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training and experience
• At least 1-2 year of Study Startup experience  
• Well-developed communication and organizational skills
• Ability to negotiate and build relationships at all levels
• Leadership, mentoring, and organizational skills
• Proficiency in Korean and English language

Additional Information

Culture And Benefits

We prioritize the well-being of our team, and as part of our commitment, we offer:

• A hybrid work arrangement with two flexible work-from-home days and three on-site days each week.
• Our office is conveniently located at Lotte Tower. 
• Opportunities for learning and professional development, English training support if required. 
• Access to mental wellness programs, onsite yoga room and lounge room for relaxation. 
• Annual medical checkup and flu vaccine support to promote our employees' health. 
• The chance to work within a meaningful industry in a global organization setting.

PSI is an inclusive and equal opportunity employer and is committed to attracting and retaining a diverse workforce that reflects the community we serve.