BeOne Medicines Ltd is seeking a Study Start-up Specialist to lead and manage clinical study start-up activities in Japan. The ideal candidate should possess at least two years of relevant experience, a scientific or healthcare degree, and strong organizational skills, while contributing to innovative cancer treatments
Job Summary
Lead the delivery of study start-up, maintenance, and closeout activities within established timelines with high quality.
Contribute to submission strategies and prepare submission packages for regulatory authorities and institutions.
BeOne is a global oncology company committed to radically improving access to medicines for cancer patients worldwide.
Matching Summary
Match Score: 85
BeOne Medicines Ltd is seeking a Study Start-up Specialist to lead and manage clinical study start-up activities in Japan. The ideal candidate should possess at least two years of relevant experience, a scientific or healthcare degree, and strong organizational skills, while contributing to innovative cancer treatments.
Skills & Requirements
Must-have
Study start-up, maintenance, and closeout
ICH/GCP and local regulations
Submission strategies and packages
Clinical trial site contract negotiation
Site feasibility and selection
Essential document collection and review
Company systems (CTMS, eTMF)
Nice-to-have
Process improvement initiatives
Therapeutic area knowledge
Building site partnerships
Mentoring junior staff
Collaborative and supportive team
Key Requirements
Bachelor's degree or higher in a scientific or healthcare discipline
At least 2 years experience in a similar role
Fluent in local language and written/verbal English