Remote Clinical Trial Start-Up Specialist

Precision for Medicine; Polska; Hybrid; PLN 80,000 - 120,000; Full time

Job summary

Precision Medicine Group is seeking a Start Up Specialist to support clinical trial regulatory activities. The role involves preparing submissions to authorities and ethics committees, coordinating with CA/EC, and maintaining regulatory plans for timely site activation and IMP release across international sites.

The ideal candidate has CRO or pharma start-up experience, a life sciences degree (or RN/Pharmacist), and fluent Hungarian and English to support diverse sites.

Qualifications

• Bachelor’s degree in life sciences or related field, or RN/Pharmacist qualification.
• Experience as Regulatory or Start Up specialist in CRO or pharma.
• Fluent in Hungarian and English.

Responsibilities

• Prepare Clinical Trial Applications and submissions to authorities and ethics committees.
• Coordinate with CA/EC and respond to inquiries.
• Maintain project plans and regulatory trackers.
• Translate and coordinate translations for documents.
• Ensure site activation and IMP release readiness.

Skills

Regulatory Start Up experience

CRO/pharma industry exposure

Regulatory submissions

Education

Bachelor’s degree in life sciences or related field

RN or Pharmacist qualification

Tools

Microsoft Office

eTMF systems

Job description

Precision Medicine Group is seeking a Start Up Specialist to support clinical trial regulatory activities. The role involves preparing submissions to authorities and ethics committees, coordinating with CA/EC, and maintaining regulatory plans for timely site activation and IMP release across international sites.

The ideal candidate has CRO or pharma start-up experience, a life sciences degree (or RN/Pharmacist), and fluent Hungarian and English to support diverse sites.