Site Contracts Specialist, All Levels – Experience in Site Agreements & Budget

This is a fully remote position, open to applicants in Brazil, +2 more states.

📋 Description

• Lead projects across multiple countries that involve negotiation and preparation of contracts, budgets, and associated documents for industry-sponsored clinical trials.

• Create and review site-specific contracts based on country clinical trial agreement templates.

• Submit proposed CTAs and investigator budgets for review at the site level.

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

• Conduct quality control and facilitate the execution and archiving of CTAs along with metadata capture.

• Oversee project-level contract management processes and coordinate related agreement documents.

• Generate revised contract and budget documents while optimizing contract/proposal and internal procedures.

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

• Validate departmental budget loads and backlog in conjunction with the SSU Lead, Clinical Operations, and Finance.

• Identify risks associated with contracts and processes and formulate solutions.

• Build relationships with SSU leads, clients, and internal project teams.

• Report deviations to leadership, the Site Contract Service Center, and Legal.

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

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

• Collaborate 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 and provide updates on contract status.

• Prepare correspondence and facilitate contract execution by company signatories.

• Train and mentor less experienced staff while maintaining training resources.

• Oversee basic project financial aspects and track contract hours/tasks, escalating any discrepancies.

• Adhere to SOPs, Work Instructions, training records, and timesheet requirements.

• Contribute to training and quality assurance plans, while updating SOPs/WIs.

⛳️ Requirements

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

• An advanced degree is preferred.

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

• Management experience is preferred.

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

• Proficient computer skills in the Microsoft Office Suite.

• Ability to manage competing priorities while remaining flexible and adaptable in high-pressure situations.

• Excellent grasp of clinical trial processes across Phases II–IV and ICH GCP.

• Good understanding of clinical protocols and their related study specifications.

• Strong knowledge of clinical trial start-up processes.

• Project management experience in a dynamic environment.

• Competent vendor management skills.

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

• Excellent communication, presentation, and interpersonal skills.

• Quality-focused mindset.

• Strong negotiating and problem-solving abilities.

• Capability to mentor and inspire junior staff.

• Ability to provide constructive feedback and support to peers.

• Contribution to a training and Quality Assurance plan within SSU and updates to SOPs/WIs are expected.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged management.

• Technical and therapeutic area training provided.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• Culture of total self.

• Initiatives promoting diversity, inclusion, and belonging.

• Access to extensive resources including emerging technologies, data, science, and knowledge sharing.

• Career path and advancement opportunities available.

• Reasonable accommodations under the Americans with Disabilities Act, as applicable.