Senior Site Contracts Specialist – Experience in Site Agreements, Budget

This is a fully remote position, open to applicants in Argentina, +1 more country.

📋 Description

• Oversee multi-national projects that involve negotiating and preparing contracts, budgets, and related documentation for industry-sponsored clinical trials.

• Create and evaluate site-specific contracts derived from country clinical trial agreement templates.

• Submit proposed Clinical Trial Agreements (CTAs) and investigator budgets for site evaluation.

• Negotiate budgets and contracts with sites, the Site Contracts Service Centre, SSUL, and sponsors.

• Conduct quality control, facilitate the execution of CTAs, archive documents, and capture metadata.

• Manage contract administration processes across protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents.

• Produce amended contract and budget documents while streamlining contract, proposal, and internal processes.

• Align site contracts with sponsor master service agreement terms in partnership with the Site Contract Service Center and Legal.

• Collaborate with SSU, Clinical Operations, and Finance to verify departmental budgets and manage backlog.

• Identify operational risks, propose solutions, and escalate any deviations.

• Assist in business development and represent site contracts/SSU at internal or client meetings.

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

• Work with legal, finance, and clinical operations teams on legal and budgetary matters.

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

• Act as a communication liaison regarding contract statuses and outstanding issues.

• Train and mentor less experienced staff members while maintaining training materials.

• Facilitate contract execution by company signatories.

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

• Ensure compliance with SOPs and WIs, maintain training records, and uphold timesheet compliance.

⛳️ Requirements

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

• Moderate experience in contract management, particularly in a contract research organization or the pharmaceutical industry.

• In-depth knowledge of the clinical development process along with legal and contracting parameters.

• Proficient computer skills in the Microsoft Office Suite.

• Strong understanding of the clinical trial process across Phases II-IV and ICH GCP.

• Good comprehension of clinical protocols and associated study specifications.

• Excellent grasp of clinical trial start-up processes.

• Experience in project management within a fast-paced environment.

• Competent vendor management skills.

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

• Outstanding communication, presentation, and interpersonal skills.

• Strong negotiation abilities.

• Effective problem-solving skills.

• Capacity to mentor and motivate junior staff.

• 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.

• Advanced degree preferred.

• Management experience preferred.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition and a comprehensive rewards program.

• A culture of total self.

• Initiatives focused on diversity, inclusion, and a sense of belonging.