Start Up Specialist - Fluent in Hungarian

About the role

Precision Medicine Group is looking for a Start Up Specialist to join its growing team. The role suits candidates at all levels who have gained some site start-up experience within a Clinical Research Organisation. Candidates based in Hungary, Poland, Serbia, Slovakia or Romania with fluency in Hungarian are welcome.

Key responsibilities

• Prepare Clinical Trial Application Forms and submission dossiers (initial and amendments) for Competent Authorities, Ethics Committees and other local bodies, following ICH-GCP, local regulations and company SOPs.
• Interact with Competent Authorities and Ethics Committees, handle their responses and keep the Start Up Lead, Regulatory Lead and Project Team informed.
• Maintain project plans, trackers and regulatory intelligence tools, and prepare study-specific start-up plans, IMP release requirements and document review criteria.
• Partner with the assigned site CRA to align communication, secure site review and collect documents needed for site activation and IMP release.
• Customize country/site-specific Patient Information Sheets and Informed Consent Forms, and coordinate translations.
• Act as subject matter expert for site-level critical path data such as CA/EC timelines, site contracts and budget requirements, and support feasibility, budget and investigator contract negotiations when asked.
• Keep up to date with local clinical trial laws and regulations, maintain audit readiness and file documents according to the TMF plan.
• Support pre-study site visits and stay in touch with feasibility, clinical operations, project management and site contracts groups.

Required profile

• Bachelor's degree in life sciences or a related field (ideally scientific or healthcare), or Registered Nurse or equivalent combination of education, training and experience.
• Demonstrated experience as a Regulatory or Start Up specialist (or comparable role) in a CRO, pharma/biotech or equivalent setting.
• Fluency in Hungarian and English; preferred: relevant regulatory and site start-up experience, milestone tracking tools, and an advanced degree (MD, PhD, PharmD) or RAC certification.
• Must be legally authorized to work in the country of employment without employer sponsorship.

Required skills

• Strong communication and organizational skills.
• Experience with computerized information systems, electronic spreadsheets, word processing and email.