Site Contracts Specialist, Hungarian Speaker

This is a fully remote position, open to applicants in Hungary, +4 more countries.

📋 Description

• Oversee contract management processes related to protocols, informed consent, institution, investigator, vendor, consultant, and customer agreements at the project level.

• Lead multi-country projects, under supervision, that involve the negotiation and preparation of contracts, budgets, and associated documents for industry-sponsored clinical trials.

• Assist in creating country-specific template contracts and budget agreements, and develop site-specific contracts.

• Aid in the negotiation of contracts and budgets with sites, the Site Contracts Service Centre, SSUL, and sponsors.

• Conduct quality control, facilitate the execution of Clinical Trial Agreements (CTAs), archive documents, and capture necessary metadata.

• Review contracts for accuracy and completeness, ensuring that any corrections are properly documented.

• Support business development initiatives and represent site contracts/Site Start-Up in internal and customer meetings.

• Address ongoing contract issues, follow up on unresolved matters, and create amended contract or budget documents as needed.

• Monitor contracting timelines and track milestone progress using the SSU tracking system.

• Collaborate with legal, finance, clinical operations, internal teams, and external stakeholders on budgetary and legal matters.

• Facilitate contract execution by company signatories.

• Maintain templates for contracts, site-specific files, and relevant databases.

• Train and mentor less experienced staff while keeping training materials updated.

• Serve as a communication liaison regarding the status of contracts and any pending issues.

• Monitor basic financial aspects of projects and contract hours/tasks, escalating any discrepancies as necessary.

• Adhere to Standard Operating Procedures (SOPs) and Work Instructions (WIs), maintain training records, and ensure compliance with timesheets.

⛳️ Requirements

• BA/BS degree in Business Administration, Public Administration, Public Health, a related field, or an equivalent combination of education and experience.

• An advanced degree is preferred.

• Extensive experience in contract management is required.

• Experience in a contract research organization or the pharmaceutical industry is essential.

• Strong understanding of the clinical development process as well as legal and contracting parameters.

• Proficient in Microsoft Office Suite.

• Excellent knowledge of the clinical trial process across Phases II-IV and adherence to ICH GCP standards.

• Familiarity with clinical protocols and associated study specifications.

• Strong grasp of clinical trial start-up processes.

• Proven project management experience in a dynamic environment.

• Competency in vendor management.

• Exceptional written and oral communication skills in both French and English.

• Solid organizational, negotiating, problem-solving, mentoring, leadership, and motivational abilities.

• Capacity to manage multiple projects and prioritize effectively under pressure.

• Ability to provide constructive feedback and guidance to colleagues.

• Capability to contribute to training and Quality Assurance plans while updating SOPs/WIs.

🏝️ Benefits

• Opportunities for career advancement and development.

• Supportive and engaged management.

• Training in technical skills and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Flexible home-based remote work arrangements.