Job Description
Position: Study Start-Up Specialist
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%)
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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