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Product Management Associate Director

Publication date 2024/04/12

Tokyo,8.0M ~ 16.0M

- Mega Pharma company with multiple pipeline and products
- Hybrid / remote work possible
- Bilingual environment (English and Japanese)
- Strong career growth

- Lead strategic planning and executions
- Drive marketing and engagement plans
- Work closely in cross-functional teams, with regional and global stakeholders
- 3-5 years experience in Marketing management is required
Location: Tokyo

Local Trial Manager (LTM)

Publication date 2024/04/12

Tokyo,10.0M ~ 12.0M

Key Activities:
? Partner with global and local country teams to provide high level country strategy and actively drive study progress and local/country level study delivery
? Accountable for study results and drives key decisions within country
? Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership with engagement of the cross-functional Local Study Team
? Contribute and develop program/study-specific materials ? e.g., monitoring plan, study specific training documents.
? Support and contribute to Clinical Study Teams / Trial Management Teams as applicable, agenda driven, present at meetings when needed
? Communicate country status (including timelines and deliverables) to key partners including updates to relevant systems for transparency
? Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country(ies)
? Manage, oversee and supervise applicable vendor activities e.g., laboratories and equipment provisioning
? Utilize local/country regulatory knowledge to contribute to IP provisioning and import/export license processes
? Actively engage and lead local cluster team from a study perspective
? Provides country level input into the Country Operational Plan (COP) and partner with the Development Feasibility Manager through feasibility and with the Global Clinical Managers to ensure local delivery of the study
? Manage, supervise, and review country and study trends
? Identify and facilitate resolution of cross-functional study-specific issues
? Provide updates regarding the study budget and obtain approval for budget deviations for clinical sites (outside of range)
? Effectively own and bring up any issues related to delivery, timelines, or budget to study team as required
? Conduct on-site quality visits with CRAs where/when appropriate and supports the maintenance of the company's investigator site relationships
? Implement regulatory agency inspection readiness activities (e.g., TMF review, story board generation)
? Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate e.g., vendor management
? Participate in cross-functional task forces/process improvement groups
? Assign and lead all aspects of deliverables of study support staff e.g., Study Management Associate
? Coordinate site contracting, budgeting, insurance and payment process by supervising local support roles
? Lead and continually review country level risk mitigation activities to ensure study delivers to plan
? Maintain relevant therapeutic knowledge
? Triage / tailor communication from study / local team to sites to ensure efficient and effective communication flow

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