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Study Start Up Specialist
Japan Tokyo, Tokyo Tokyo JP
Job Description
Employment Type: Permanent
Location: Remote (Japan / APAC-aligned)
Note: Both Japanese and English CVs are required
Company Overview
The client is a top-tier global pharmaceutical organisation with a strong focus on research and development and a significant presence across APAC and other major regions. The organisation is committed to developing innovative therapies for unmet medical needs and operates under high standards of ethics, quality, and regulatory compliance.
Role Summary
This role sits within Clinical Operations Excellence and acts as a local subject matter expert for Study Start-Up (SSU) activities. The Study Start-Up Specialist supports site-facing activities and partners closely with global SSU teams to ensure efficient, consistent, and compliant site activation.
The role involves hands-on coordination of SSU activities, use of clinical systems (e.g. CTMS), and close collaboration with study teams and sites. This position does not have direct reports but may provide guidance to contract staff.
Key Responsibilities
- Support day-to-day Study Start-Up activities to ensure delivery against timelines and objectives in compliance with GCP / ICH and applicable regulations
- Coordinate closely with study teams and key stakeholders to support timely site activation
- Generate and maintain accurate project status and tracking information in relevant clinical systems
- Proactively identify, escalate, and support resolution of SSU-related issues
- Support implementation of SSU standards and processes for the assigned region
- Oversee site-level SSU activities from site selection through activation, including:
- Confidentiality agreements and site questionnaires
- Informed Consent Form (ICF) negotiation and escalation
- IRB / EC submissions and approvals
- IMP release and other activation requirements
- Support execution of the SSU strategy during the study start-up phase
- Build strong working relationships with internal stakeholders and site staff
- Track and forecast site activation timelines and escalate risks or delays
- Lead preparation of study-level essential document templates
- Support preparation of content for regulatory submissions
- Prepare and submit IMP Release Packages
- Maintain accurate, timely data in clinical trial systems
- Ensure ongoing compliance with applicable regulations and internal processes
Qualifications
Required
- Bachelor’s or Associate degree with 2+ years’ experience in healthcare or clinical trial-related roles
- Working knowledge of clinical trial conduct
- General understanding of drug development and ICH / GCP guidelines
- Demonstrated project management capability
- Strong interpersonal, written, and verbal communication skills
- Strong administrative and computer skills
- Fluent in English
- Minimal travel required (0–5%)
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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