Study Startup Specialist I/II at PSI CRO

Seoul, , South Korea -

Full Time

Start Date

Immediate

Expiry Date

20 Jun, 26

Salary

0.0

Posted On

22 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Study Startup, Site Budgets, Contract Negotiations, Regulatory Document Collection, Submission Dossiers Preparation, Communication, Organizational Skills, Leadership, Mentoring, Timeline Development, Trial Master File (TMF) Maintenance, English, Korean

Industry

Pharmaceutical Manufacturing

Description

Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. PSI’s business is about conducting clinical research of novel medications. We work at the interface of R&D, pharmaceutical industry and healthcare science and provide services to big and mid-sized pharmaceutical companies. We help our clients to generate data about safety and efficacy of medications and bring the best ones to market. By conducting global clinical research trials, PSI makes cutting-edge treatment available in drugstores all over the world and helps patients with serious medical conditions to improve or even save their life. Help us to make sure that PSI medical and business documents are clear to patients, physicians, regulatory authorities, and clients. 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 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 2-3 year of Study Startup experience in the Korea, 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.

Responsibilities

The specialist will lead challenging study activation processes at the country level to ensure clinical research projects start smoothly and on time. Key duties include maintaining tracking systems, facilitating site contracts and budgets, and supporting regulatory document collection and submissions.