Start-Up in Tokyo | Careerjet


Global top-scale CRO

2020/10/06 UP

Recruitment Position Senior Site Start-Up & Regulatory Specialis
Work location Tokyo

Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. Responsible for providing delivery and expertise, with minimal oversight from the SSU Country Manager in one or more of the following functional areas: investigator Accountable local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards. Ensures an efficient start-up process on assigned studies. Site contracts, ethics and regulatory submissions, and review and finalization of essential documents required for site initiation. May act as main contact with Regulatory Authorities (RA) and Central / Regional Ethics Committees (ECs). Under the direction of the Project Lead (PL) or SSUL as appropriate, may direct
Qualifications ■ Bachelor’s Degree
Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
Good understanding clinical protocols and associated study specifications
Excellent understanding of clinical trial start-up processes
Project management experience in a fast-paced environment
Good vendor management skills
Strong organizational skills with proven ability to handle multiple projects
Excellent communication, presentation and interpersonal skills

Annual income 7.5 million yen-9 million yen
Employment form Full-time employee
About companies[Overview / Features]
■ The company is a foreign-affiliated CRO that supports clinical development globally.
■ The projects that the company has received are mainly global tests.

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