5 часов назад
Project Manager, FSA (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Project Manager, FSA (Clinical Research): Planning and managing feasibility and site activation activities for clinical studies with an accent on study start-up planning, regulatory submissions, essential document collection, and milestone control. Focus on coordinating cross-functional stakeholders, identifying activation risks, and delivering site start-up activities within quality and timeline expectations.
Location: Osaka or Tokyo, Japan; remote or office-based work available
Company
is a healthcare intelligence and clinical research organization supporting clinical development.
What you will do
- Plan and manage feasibility and site activation project plans, timelines, budgets, resources, and deliverables.
- Coordinate feasibility assessments, country and site recommendations, and site activation strategies with functional experts.
- Oversee essential document collection, ethics and regulatory submissions, contract-related activities, and activation milestones.
- Track progress against timelines and KPIs, identify risks, and implement mitigation plans.
- Act as the primary FSA contact for internal teams, sponsors, and customers on study start-up matters.
- Support audits and inspections as an FSA representative and contribute to process improvements.
Requirements
- Bachelor’s degree in life sciences, healthcare, business, or a related field, or equivalent experience.
- Experience leading or supporting clinical trial start-up activities, including feasibility, site activation, budgets, resources, or Site Activation Plans.
- Experience as a Project Manager or Clinical Trial Manager is required.
- Understanding of regulatory, ethics, and contractual requirements affecting study start-up.
- Strong project planning, organizational, communication, and stakeholder management skills.
- Business-level English is required. Willingness to travel approximately 10% as needed.
Culture & Benefits
- Inclusive and accessible work environment focused on diversity, belonging, and equal opportunity.
- Annual leave and country-specific benefits.
- Health insurance options for employees and families.
- Retirement planning, life assurance, and employee assistance support.
- Optional benefits may include childcare vouchers, gym memberships, travel subsidies, and health assessments.
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