Site Contracts Specialist II – Sponsor Dedicated

This is a fully remote position, open to applicants in Hungary, +2 more countries.

📋 Description

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

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

• Assist with country-specific template contracts and budget agreements, and generate site-specific contracts.

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

• Conduct quality control and organize the execution and archival of clinical trial agreements, along with metadata capture.

• Review contracts for thoroughness and accuracy, documenting any necessary corrections.

• Support business development efforts and represent site contracts/Site Start-Up during internal or client meetings.

• Actively manage ongoing contract issues and follow up on unresolved matters.

• Generate revised contract and budget documents while streamlining contract, proposal, and internal processes.

• Monitor country/site contracting timelines and milestone progress in the SSU tracking system.

• Collaborate with legal, finance, and clinical operations teams on legal and budgetary concerns.

• Facilitate contract execution by company signatories.

• Maintain contract templates, site-specific files, and databases.

• Train and mentor less experienced staff on SOPs and ensure the quality of team outputs.

• Update and maintain training materials for the site contract team.

• Serve as a liaison between site contracts staff and internal/external customers regarding contract statuses and outstanding issues.

• Monitor basic project financial elements and contract hours/tasks while escalating discrepancies.

• Review and adhere to SOPs and WIs, update 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 contracts management is required.

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

• Strong understanding of the clinical development process along with legal and contracting parameters.

• Proficient computer skills in Microsoft Office Suite.

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

• Good understanding of clinical protocols and related study specifications.

• Exceptional knowledge of clinical trial start-up processes.

• Project management experience in a dynamic environment.

• Strong vendor management capabilities.

• Outstanding written and oral communication, presentation, documentation, interpersonal skills, and a strong team-oriented approach.

• Excellent organizational skills with a proven ability to manage multiple projects simultaneously.

• Strong negotiation and problem-solving abilities.

• Capacity to mentor, lead, and motivate junior staff members.

• Ability to provide constructive feedback and guidance to peers.

• Capability to contribute to a training and Quality Assurance plan within SSU and update SOPs/WIs as necessary.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition programs.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations provided when appropriate under the Americans with Disabilities Act.