Clinical Start-Up Specialist (Remote, Regulatory & Activation)

Jobicy; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Precision Medicine Group is hiring a Start Up Specialist to support regulatory submissions and site activation for clinical trials. The role will involve preparing CTAs, coordinating with Competent Authorities and Ethics Committees, and maintaining regulatory trackers across multiple sites.

Ideal candidates have site start-up experience in CRO or biotech, fluent Hungarian and English, and a background in life sciences.

Qualifications

• Bachelor’s degree in life sciences or related field, or RN or equivalent.
• Pharmacist/Pharmacy qualification would be highly beneficial.
• Regulatory or Start Up experience in CRO or pharma/biotech industry.

Responsibilities

• Prepare Clinical Trial Application Forms and submission dossiers for authorities and ethics committees.
• Interact with CA/EC for study purposes and manage responses.
• Maintain project plans and regulatory trackers; update regulatory leadership.
• Coordinate translations and country/site start-up documents.
• Ensure site activation and budget negotiations align with timelines.

Skills

Regulatory Start Up experience

Clear communication

Organization

Hungarian fluency

English fluency

Education

Bachelor’s degree in life sciences or related field

RN or PharmD beneficial

Job description

Precision Medicine Group is hiring a Start Up Specialist to support regulatory submissions and site activation for clinical trials. The role will involve preparing CTAs, coordinating with Competent Authorities and Ethics Committees, and maintaining regulatory trackers across multiple sites.

Ideal candidates have site start-up experience in CRO or biotech, fluent Hungarian and English, and a background in life sciences.