[All remote jobs](https://jobicy.com/jobs.md)[![Precision Medicine Group logo](https://jobicy.com/data/server-nyc0409/galaxy/mercury/2025/06/f1277044-221.jpg)](https://jobicy.com/company/precision-medicine-group.md)[Precision Medicine Group](https://jobicy.com/company/precision-medicine-group.md) # Start Up Specialist – Fluent in Hungarian Review the role, location requirements, compensation details, and application process before deciding whether this opportunity fits your next career move. [Apply for this job](#job-application)[View company](https://jobicy.com/company/precision-medicine-group.md)ShareRemote from[Romania](https://jobicy.com/job-region/romania.md), [Poland](https://jobicy.com/job-region/poland.md), [Hungary](https://jobicy.com/job-region/hungary.md)+2 more, [Slovakia](https://jobicy.com/job-region/slovakia.md), [Serbia](https://jobicy.com/job-region/serbia.md)SalaryUndisclosedDepartment[Healthcare & Medical](https://jobicy.com/categories/healthcare.md)EmploymentFull TimeExperienceSeniorPublished28 Oct 2026Apply before27 Nov 2026Listing views42Application actions1Application toolkit ## Make your next move. Prepare your resume, explore your fit, and draft a cover letter for this opportunity. AI Summary ## The role, at a glance. Precision Medicine Group is seeking a remote Start Up Specialist to support clinical trial start-up activities for Hungarian sites. The role manages regulatory submissions to competent authorities and ethics committees, essential documents, site activation milestones, translations, and cross-functional status communication. Candidates need CRO or pharmaceutical/biotech start-up or regulatory experience, fluency in Hungarian and English, and knowledge of local clinical trial requirements. The position is open to professionals based in Hungary, Poland, Serbia, Slovakia, or Romania and may include support for site budget and investigator-contract processes. Strong organization, regulatory accuracy, and coordination across clinical operations teams are central to success. ## Role DNA A quick view of the complexity, pace, ownership and collaboration implied by the job description. ### Job Complexity 4/5EasyHard ### Pace & Pressure 4/5RelaxedFast-paced ### Autonomy Level 4/5GuidedFull ownership ### Communication Load 5/5IndependentCollaborative AI insightThe role requires careful application of local clinical-trial regulations, ICH-GCP principles, and time-sensitive authority and ethics submissions. It also involves coordinating several stakeholders while maintaining inspection-ready documentation and activation timelines. ## Salary analysis Estimated compensation compared with the broader US market for similar roles. Estimated job median (per year)Highly competitive$95,000US market range (per year)$80k–$110k0$121.00k AI insightThe yearly pay period is inferred from the job context; it was not explicitly stated by the employer. No employer salary was disclosed. The yearly cadence is inferred from the regular full-time specialist role; estimated US-market annual compensation for a clinical trial start-up specialist is approximately $80,000–$110,000, with a midpoint of $95,000. ## Core skills Skills and capabilities most closely associated with this opportunity. [Clinical trial start-up](https://jobicy.com/jobs?search_keywords=Clinical%20trial%20start-up.md)[Regulatory submissions](https://jobicy.com/jobs?search_keywords=Regulatory%20submissions.md)[ICH-GCP](https://jobicy.com/jobs?search_keywords=ICH-GCP.md)[Ethics committee submissions](https://jobicy.com/jobs?search_keywords=Ethics%20committee%20submissions.md)[Competent authority interaction](https://jobicy.com/jobs?search_keywords=Competent%20authority%20interaction.md)[Site activation](https://jobicy.com/jobs?search_keywords=Site%20activation.md)[Clinical trial applications](https://jobicy.com/jobs?search_keywords=Clinical%20trial%20applications.md)[Regulatory intelligence](https://jobicy.com/jobs?search_keywords=Regulatory%20intelligence.md)[Essential document management](https://jobicy.com/jobs?search_keywords=Essential%20document%20management.md)[Trial master file management](https://jobicy.com/jobs?search_keywords=Trial%20master%20file%20management.md)[Milestone tracking](https://jobicy.com/jobs?search_keywords=Milestone%20tracking.md)[Site contract support](https://jobicy.com/jobs?search_keywords=Site%20contract%20support.md)[Hungarian language fluency](https://jobicy.com/jobs?search_keywords=Hungarian%20language%20fluency.md)[English language fluency](https://jobicy.com/jobs?search_keywords=English%20language%20fluency.md)[Cross-functional coordination](https://jobicy.com/jobs?search_keywords=Cross-functional%20coordination.md) Sample interview questionsDescribe your experience preparing and submitting clinical trial applications or substantial amendments.I have coordinated submission packages by validating required country-specific documents, completing application forms, tracking deadlines, and ensuring that supporting materials were consistent before submission to competent authorities and ethics committees. I maintained a clear tracker for questions, responses, approvals, and amendment status. How do you ensure compliance with local regulations and ICH-GCP during site start-up? I begin by reviewing current local requirements, study-specific procedures, and ICH-GCP expectations. I use documented checklists, keep regulatory intelligence current, verify essential documents before activation, and escalate any uncertainty to the regulatory or start-up lead promptly. How would you manage competing start-up deadlines across several Hungarian sites? I would maintain a milestone-based tracker that identifies critical-path dependencies, authority and ethics committee timelines, document ownership, and escalation dates. I prioritize items that block activation, set regular follow-ups with sites and internal partners, and communicate risks early with practical recovery actions. Give an example of how you would handle a question from an ethics committee or competent authority. I would review the question with the relevant study documents and subject-matter experts, determine the required response and approval path, and prepare a clear, accurate reply within the requested timeline. I would document the correspondence, submit through the appropriate channel, and update the project team and tracker. How do you work effectively with CRAs, project managers, regulatory colleagues, and site contract teams? I establish clear responsibilities, shared timelines, and concise status reporting from the outset. I communicate site-specific blockers early, confirm actions and due dates after discussions, and use trackers to keep all functions aligned on the path to site activation. Opportunity details ## About this role. 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 an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. As our company continues we grow we are seeking a Start Up Specialist to join our growing team. For this position, we are open to candidates at all levels, who have acquired some Site Start Up experience gained from within a Clinical Research Organisation. We are open to candidates located in Hungary, Poland, Serbia, Slovakia or Romania with fluency in Hungarian. Essential functions of the job include but are not limited to: * Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. * Interaction with CA/EC for study purposes and handling responses to the CA/EC. * Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team * Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership * Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. * Partner with the 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. * Responsible for/facilitates the translation and co-ordination of translations for documents. * Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. * Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. * When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. * May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. * Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. * Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF * May support the clinical team performing Pre-Study Site Visits. The ideal candidate will have: Minimum Required: * Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. * A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial. * Demonstrated experience as a Regulatory or Start Up specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. Other Required: * Strong communication and organizational skills. * Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. * Must be fluent in Hungarian and English, as you will be supporting Hungarian sites Preferred: * 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. #LI-OS1 #LI-Remote Any data provided as a part of this application will be stored in accordance with our [Privacy Policy.](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fprivacy-policy%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=9DgboiHTFPrNYVhdKhyfdwVyNYwUvZbP%2FroLdWIIfxw%3D&reserved=0) For CA applicants, please also refer to our [CA Privacy Notice](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fca-applicants-privacy-notice%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=tfAqqMZsG%2B11IchL45HFFVbfECCkYqQpNr0PQxrMFJU%3D&reserved=0). Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [myHR@precisionmedicinegrp.com](mailto:myHR@precisionmedicinegrp.com). Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at [myHR@precisionmedicinegrp.com](mailto:myHR@precisionmedicinegrp.com) so we can investigate and take appropriate action. Candidates must be legally authorized to work in the country of employment without employer sponsorship. Show more [Apply now >](https://jobicy.com/jobs/157682-start-up-specialist-fluent-in-hungarian.md) > Annual salary information is not provided for this position. 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