Site Contracts Specialist, Polish Required

This is a fully remote position, open to applicants in Poland.

📋 Description

• Oversee the contract management procedures for protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at the project level.

• Lead multi-country projects involving the negotiation and preparation of contracts, budgets, and related clinical trial documentation, under supervision.

• Assist in reaching agreements on country-specific template contracts and budgets.

• Create site-specific contracts derived from country templates.

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

• Conduct quality control and coordinate the execution and archival of clinical trial agreements while capturing relevant metadata.

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

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

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

• Create amended contract and budget documents, while optimizing contract, proposal, and internal processes.

• Monitor contracting milestones against projected country/site timelines in the SSU tracking system.

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

• Facilitate the execution of contracts by company signatories.

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

• Train and mentor junior staff on SOPs, ensuring high quality in team deliverables.

• Keep training materials for the site contract team current and updated.

• Serve as the communication liaison between site contracts staff and internal/external customers.

• Update on contract statuses and pending issues, preparing necessary correspondence.

• Monitor fundamental project financial aspects and contracted hours/tasks, reporting any discrepancies.

• Adhere to SOPs and Work Instructions, maintain training records, and ensure compliance with timesheets.

⛳️ Requirements

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

• An advanced degree is preferred.

• Extensive experience in contracts management.

• 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 in Microsoft Office Suite with strong computer skills.

• Customer-oriented, flexible, adaptable, and capable of managing competing priorities in high-pressure situations.

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

• Solid understanding of clinical protocols and associated study specifications.

• Thorough knowledge of clinical trial start-up processes.

• Proven project management experience in a fast-paced environment.

• Competent vendor management skills.

• Exceptional written and verbal communication, presentation, documentation, interpersonal, and teamwork skills.

• Strong organizational abilities with the capacity to manage multiple projects simultaneously.

• A quality-driven approach.

• Strong negotiation and problem-solving capabilities.

• Ability to mentor, lead, and inspire junior staff.

• Capacity to offer constructive feedback and guidance to peers.

• Ability to contribute to a training and Quality Assurance plan within SSU and revise SOPs/WIs.

• Proficiency in Polish is required.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Recognition among peers.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Reasonable accommodations provided when appropriate.