ROW Study Start-Up Specialist II – Remote in Australia

Caidya; Australia; Remote; AUD 70,000 - 110,000; Full time

Job summary

Caidya is seeking a Study Start-Up Country Specialist II (ROW) to support Australia-based country start-up activities. You will manage regulatory submissions, translations, and site interactions to ensure timely study initiation.

Working with the SSU Manager and project teams, you will coordinate CDA processes, review essential documents, and track submission status across assigned countries in accordance with ICH-GCP and local regulations.

Qualifications

• Bachelor's graduate with a healthcare or life science degree or equivalent experience.
• 3+ years as SSU Specialist or Regulatory Specialist, preferably in CRO/pharma.
• Proficient in ICH-GCP guidelines and medical terminology.

Responsibilities

• Independently provides country-level expertise and support to SSU and project teams.
• Assists with CDAs and intermediation for engagement with sites.
• Builds relationships with sites and investigators in country of expertise.
• Participates in site and investigator identification and submission strategy.
• Facilitates distribution/collection of Feasibility Questionnaires to sites.
• Reviews and coordinates regulatory submission documents and Essential Document Release.
• Translates/reviews local language documents for regulatory interactions.
• Supports creation/review of regulatory documents for CTAs and submissions.
• Maintains submission information in tracking systems and TMF.
• Coaches or onboarding junior specialists as needed.
• Contributes to functional improvement initiatives.

Skills

Regulatory submissions

ICH-GCP knowledge

Regulatory liaison

Document translation

Project coordination

English proficiency

Education

Bachelor's in Life Sciences

Tools

Microsoft Office

Job description

Caidya is seeking a Study Start-Up Country Specialist II (ROW) to support Australia-based country start-up activities. You will manage regulatory submissions, translations, and site interactions to ensure timely study initiation.

Working with the SSU Manager and project teams, you will coordinate CDA processes, review essential documents, and track submission status across assigned countries in accordance with ICH-GCP and local regulations.