MANDATORY

• Applicants must have permission to work in Japan
• Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)

☑Foreign business ☑Japanese language required

[Position]
Study Startup Manager

[Company Description]
Global Pharmaceutical Company

[Responsibilities]

• Coordination and administration of start-up activities of clinical studies from site identification through site activation
• Obtain and maintain essential documentation in compliance with ICH-GCP and other Procedural Documents.
• Under supervision from the COM Team and other relevant stakeholders (i.e. Legal, ClinOps, etc.), assist in negotiations of budget and contract with site resolution of issues and contract execution.
• Assists in producing and collecting site-specific contracts, ICFs and CDAs from country and/or master template.
• Coordinates with relevant stakeholders to generate responses to Ethics/IRB, RA queries during the evaluation period of the study; proceeds with submission of the responses within timelines
• Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC/IRBs, and other Regulatory Authorities as needed within
• the country; includes safety notifications as required by local regulations, with oversight from the COM team.
• Share information (metrics) on study site progress towards activation within local clinical study teams and Senior Management as required.
• Drive delivery of regulatory documents at the sites. Proactively identify delays in start-up activities and the risks to the activation plan. Review and collect essential regulatory documents for filing in eTMF
• Set-up, populate and accurately maintain information in Company's tracking and communication tools (e.g. Veeva Vault, SharePoint etc.) and support others in the usage of these systems.
• Coordinates with local COM team for preparation and submission of regular study progress reports
• Ensure regulatory binders and study supplies are provided for study site start-up and/or delivered as per start-up process and agreement with the clinical study team
• Confirms debarment status of potential investigators
• Acts as a Sponsor local person for the regular update of local clinical trial registries according to local regulations, as applicable
• May oversee Study Startup associates to ensure quality and compliance throughout the study startup process

[Requirements]
Mandatory:

• English Language level: Business level
• Minimum 4 years of Study Startup experience
• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
• Bachelor's degree in related discipline, preferably in life science, or equivalent qualification
• Excellent knowledge of relevant local regulations.
• Good medical knowledge and ability to learn relevant Therapeutic Areas.
• Basic understanding of the drug development process.

[Location]
Tokyo

[Salary]
7.0 million yen - 9.5 million yen (Experiences and skills will be considered)

[Welfare]
Social insurance

[Holidays]

• Full 2 holiday week system (Sat/Sun) national holidays
• New year's holiday
• Annual Leave

[Selection Process]
Application screening and several interviews are scheduled.

Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.

Reference: JO-2301-477717
#LI-Onsite
Seniority Level: Mid-Senior level
Job Function: Management, Research, Analyst