• Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
• May lead (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
• Provides support to SSUL to agree on country template contract and budget.
• Produces site-specific contracts from country template.
• Provide support in submissions for proposed contract and budget for site.
• Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.
• Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
• Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
• Provides supports to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
• Work with Contract Managers and team members with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.
• Support in generating amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; and initiates and introduces creative ideas and solutions.
• Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.
• Collaborates with internal and external legal, finance, and clinical operations departments,



including communicating and explaining legal and budgetary issues.
• Facilitates the execution of contracts by company signatories.
• Maintains contract templates and site specific files and databases.
• Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensures quality of team work products.
• Maintains and updates training material for site contract team.
• Acts as a communication liaison between site contracts staff and internal and external customers.
• Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues.
• Prepares correspondence as necessary.
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.RequirementsBA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience.Advanced degree preferred.Legal background (e.g. Law degree) is a plus.High level of contracts management experience.Experience in clinical research site contracts, including contract negotiations, budget development/review,



and management of clinical agreements.Experience in a contract research organization or pharmaceutical industry essential.Strong knowledge of the clinical development process and legal and contracting parameters.Strong computer skills in Microsoft Office Suite.Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.Good understanding clinical protocols and associated study specifications.Excellent understanding of clinical trial start-up processes.Project management experience in a fast-paced environment.Good vendor management skills.Excellent written/oral communication, presentation, documentation, interpersonal skills as well as strong team-orientation.Strong organizational skills with proven ability to handle multiple projects.Core CompetenciesDemonstrates expertise in contract management processes, including negotiation, budget development, and compliance with clinical trial regulations.
Proficient in project management and vendor management within the clinical research environment.Highest-signal resume keywordsContract Management ExperienceClinical Research Site ContractsBudget Development/ReviewProject Management ExperienceStrong Knowledge of Clinical Development ProcessATS Optimization KeywordsHard SkillsContract NegotiationBudget ManagementClinical Trial Process UnderstandingClinical Protocols KnowledgeQuality ControlMetadata CaptureSOP ComplianceDocument ArchivalContract Management DocumentationSite-Specific Contracts ProductionSoft SkillsExcellent Communication SkillsInterpersonal SkillsOrganizational SkillsTeam OrientationPresentation SkillsIndustry KeywordsClinical TrialsPharmaceutical IndustryContract Research OrganizationICH GCPClinical DevelopmentTools & TechnologiesMicrosoft Office SuiteSSU Tracking System
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📌 Strategic Site Contracts Lead For Clinical Trials (Buenos Aires)
🏢 Jobtailor
📍 Buenos Aires