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

Posted Aug 14

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

πŸ“‹ Description

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

β€’ Create and review site-specific contracts based on country clinical trial agreement templates.

β€’ Submit proposed CTAs and investigator budgets for review at the site level.

β€’ Negotiate budgets and contracts with sites, the Site Contracts Service Centre, SSUL, and sponsors.

β€’ Conduct quality control and facilitate the execution and archiving of CTAs along with metadata capture.

β€’ Oversee project-level contract management processes and coordinate related agreement documents.

β€’ Generate revised contract and budget documents while optimizing contract/proposal and internal procedures.

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

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

β€’ Identify risks associated with contracts and processes and formulate solutions.

β€’ Build relationships with SSU leads, clients, and internal project teams.

β€’ Report deviations to leadership, the Site Contract Service Center, and Legal.

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

β€’ Monitor country/site contracting timelines and milestone progress using the SSU tracking system.

β€’ Collaborate with legal, finance, and clinical operations teams on legal and budgetary matters.

β€’ Maintain contract templates, budget templates, site-specific files, and databases.

β€’ Act as a communication liaison and provide updates on contract status.

β€’ Prepare correspondence and facilitate contract execution by company signatories.

β€’ Train and mentor less experienced staff while maintaining training resources.

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

β€’ Adhere to SOPs, Work Instructions, training records, and timesheet requirements.

β€’ Contribute to training and quality assurance plans, while updating SOPs/WIs.


⛳️ Requirements

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

β€’ An advanced degree is preferred.

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

β€’ Management experience is preferred.

β€’ Strong understanding of the clinical development process along with legal and contracting parameters.

β€’ Proficient computer skills in the Microsoft Office Suite.

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

β€’ Excellent grasp of clinical trial processes across Phases II–IV and ICH GCP.

β€’ Good understanding of clinical protocols and their related study specifications.

β€’ Strong knowledge of clinical trial start-up processes.

β€’ Project management experience in a dynamic environment.

β€’ Competent vendor management skills.

β€’ Exceptional organizational skills with the capability to manage multiple projects simultaneously.

β€’ Excellent communication, presentation, and interpersonal skills.

β€’ Quality-focused mindset.

β€’ Strong negotiating and problem-solving abilities.

β€’ Capability to mentor and inspire junior staff.

β€’ Ability to provide constructive feedback and support to peers.

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


🏝️ Benefits

β€’ Opportunities for career development and progression.

β€’ Supportive and engaged management.

β€’ Technical and therapeutic area training provided.

β€’ Peer recognition initiatives.

β€’ Comprehensive total rewards program.

β€’ Culture of total self.

β€’ Initiatives promoting diversity, inclusion, and belonging.

β€’ Access to extensive resources including emerging technologies, data, science, and knowledge sharing.

β€’ Career path and advancement opportunities available.

β€’ Reasonable accommodations under the Americans with Disabilities Act, as applicable.

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