Site Contracts Specialist – LATAM Experience

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

📋 Description

• Oversee the contract management procedures for project-level agreements, including protocols, informed consents, institution, investigator, vendor, consultant, and customer contracts.

• Lead or assist in the contracting process for multi-country clinical trials, which involves negotiating and drafting contracts, budgets, and related documentation.

• Aid in the development of country-specific template contracts and budget agreements, and create site-specific contracts.

• Present proposed contracts and budgets for sites and negotiate any issues with sites, sponsors, and internal teams.

• Execute quality control measures, facilitate the signing of clinical trial agreements, archive documents, and capture relevant metadata.

• Examine contracts for completeness and precision, documenting any required corrections.

• Assist with business development initiatives and represent site contracts/Site Start-Up in internal and client meetings.

• Manage ongoing contract-related issues and ensure follow-up on outstanding items.

• Produce amended contracts and budgets, prepare necessary contract management documentation, and improve processes.

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

• Collaborate with legal, finance, clinical operations, vendors, sponsors, and other internal and external stakeholders.

• Facilitate contract execution by authorized company signatories.

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

• Provide training and mentorship to less experienced staff, offering functional guidance and constructive feedback.

• Serve as a communication liaison regarding contract statuses and any pending issues.

• Oversee the financial aspects of projects and contracted hours/tasks, escalating discrepancies as necessary.

• Review and adhere to SOPs and Work Instructions, ensuring compliance with timesheet submissions.

• Contribute to SSU training and quality assurance initiatives, updating SOPs/WIs as needed.

⛳️ Requirements

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

• An advanced degree is preferred.

• Extensive experience in contract management is required.

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

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

• Proficient in Microsoft Office Suite.

• Capable of managing competing priorities while remaining flexible and adaptable in high-pressure situations.

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

• Solid understanding of clinical protocols and related study specifications.

• Strong grasp of clinical trial start-up processes.

• Experience in project management within a dynamic environment.

• Competent vendor management skills.

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

• Strong team-oriented mindset and organizational skills.

• Proven capability to manage multiple projects simultaneously.

• Quality-focused approach.

• Excellent negotiating and problem-solving skills.

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

• Proficiency in providing constructive feedback and guidance to peers.

• Capacity to contribute to training and quality assurance plans within SSU and to update SOPs/WIs accordingly.

🏝️ Benefits

• Opportunities for career development and advancement.

• Support from engaged and encouraging line management.

• Access to technical and therapeutic area training.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive and welcoming culture.

• Extensive resources, including emerging technologies, data, science, and knowledge sharing.

• Clear career paths and employment opportunities.

• Reasonable accommodations provided when appropriate.