Start Up Specialist - Fluent in Hungarian

The role

The Start Up Specialist prepares Clinical Trial Application Forms and submission dossiers for Competent Authorities and Ethics Committees. This person manages site activation documents, coordinates translations, and maintains communication with key project functions.

What you will do

• Preparation of Clinical Trial Application Forms and submission dossiers for Competent Authorities and Ethics Committees.
• Interaction with CA/EC for study purposes and handling responses.
• Providing regular updates about CA and EC submissions to the Start Up Lead, Regulatory Lead, and Project Manager.
• Maintenance of project plans, project trackers and regulatory intelligence tools.
• Preparation and support of study specific start-up plans and IMP release requirements.
• Partner with assigned site CRA to ensure alignment in communication and secure site.
• Review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Form.
• Facilitate the translation and co-ordination of translations for documents.
• Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management groups.

Required qualifications

• Bachelor’s degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• Demonstrated experience as a Regulatory or Start Up specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent.
• Strong communication and organizational skills.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail.
• Must be fluent in Hungarian and English.

Nice to have

• Qualification in Pharmacy/ work experience as a Pharmacist
• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience.
• Experience using milestone tracking tools/systems.
• Ability to prioritise workload to meet deadlines
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science.

Before you apply

• Candidates must be legally authorized to work in the country of employment without employer sponsorship.

About the company

Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and a passion for rare diseases and oncology.