Study Start-Up Country Specialist II - Remote AU

Caidya; Australia; Remote; AUD 90,000 - 120,000; Full time

Job summary

Taleo in Australia seeks a Study Start-Up Country Specialist II (ROW) to lead country-level SSU activities, including regulatory submissions and site contracts, within a collaborative project team. This role emphasizes strong communication and adherence to ICH-GCP timelines while translating and reviewing regulatory documents.

Eligible candidates will be fluent in English and the local language, with at least a Bachelor’s in healthcare or life sciences and a minimum of three years of

Qualifications

• Bachelor’s degree in healthcare or life sciences or equivalent experience.
• Fluent in English and local language.
• Strong written and verbal communication skills.

Responsibilities

• Independently provides country-level SSU expertise to project teams.
• Assist in CDAs and facilitate intermediation for site agreements.
• Build relationships with sites and investigators in country of expertise.
• Support submission strategies and timelines for Regulatory Bodies.
• Prepare and review regulatory documents and translation of local language materials.
• Quality check submission dossiers when needed.
• Coordinate data entry of SSU status and regulatory documents.
• May coach or onboard junior specialists.

Skills

Fluent English

Local language fluency

Education

Bachelor’s degree in healthcare or life sciences

Job description

Taleo in Australia seeks a Study Start-Up Country Specialist II (ROW) to lead country-level SSU activities, including regulatory submissions and site contracts, within a collaborative project team. This role emphasizes strong communication and adherence to ICH-GCP timelines while translating and reviewing regulatory documents.

Eligible candidates will be fluent in English and the local language, with at least a Bachelor’s in healthcare or life sciences and a minimum of three years of