Site Contracts Specialist II – Sponsor-dedicated

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

📋 Description

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

• With guidance, lead multi-country projects that involve the negotiation and preparation of contracts, budgets, and associated clinical trial documentation.

• Assist in the agreement of country-specific contract templates and budgets.

• Generate site-specific contracts derived from country templates.

• Aid in the submission process for proposed site contracts and budgets.

• Negotiate budgets and contracts with sites, the Site Contracts Service Centre, SSUL, and the Sponsor until all issues are resolved.

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

• Review contracts to ensure completeness and accuracy, documenting any necessary corrections.

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

• Manage ongoing contract-related issues and follow up on unresolved matters.

• Create amended contract and budget documents as required.

• Prepare documentation for contract management and streamline internal processes related to contracts and proposals.

• Monitor country/site contracting milestones and ensure compliance with forecasted timelines in the SSU tracking system.

• Collaborate with legal, finance, and clinical operations teams on legal and budget-related matters.

• Facilitate contract execution by authorized company signatories.

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

• Train and mentor junior staff on standard operating procedures (SOPs) while ensuring the quality of team outputs.

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

• Act as a communication liaison between site contracts personnel and internal as well as external stakeholders.

• Monitor contract statuses, outstanding issues, project financial aspects, and available contract hours/tasks.

• Review and adhere to SOPs and work instructions (WIs), maintain training records, and ensure compliance with timesheets.

⛳️ Requirements

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

• An advanced degree is preferred.

• Extensive experience in contract 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.

• Customer-oriented with the ability to manage competing priorities while remaining flexible and adaptable in high-pressure situations.

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

• Good knowledge of clinical protocols and related study specifications.

• Solid understanding of clinical trial start-up procedures.

• Experience in project management within a dynamic environment.

• Competent vendor management skills.

• Exceptional written and verbal communication, presentation, documentation, interpersonal, and team-oriented abilities.

• Strong organizational skills with the capability to manage multiple projects simultaneously.

• Quality-driven mindset.

• Proficient negotiation skills.

• Strong problem-solving abilities.

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

• Ability to provide constructive feedback and guidance to peers.

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

• Equivalent experience, skills, and/or education may be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations when appropriate.