Senior Specialist

Worldwide Clinical Trials

. Develop, review, and assist with negotiation of Site Agreements with institutions and investigators .

Posted 9/15/2026full-timeRemote • North Carolina • United StatesSenior💰 $71,500 - $142,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in contract negotiation and management within clinical trials, including proficiency in budgeting, regulatory compliance, and collaboration with cross-functional teams. Strong understanding of ICH and GCP guidelines, along with the ability to handle complex contract terms and maintain effective communication with stakeholders.

Highest-signal resume keywords

Contract NegotiationClinical Trial AgreementsBudget ManagementRegulatory ComplianceProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Contract ManagementBudgetingNegotiation SkillsLegal TerminologyClinical Trial RegulationsGCP GuidelinesICH GuidelinesFinancial PrinciplesSite Agreement DevelopmentQuality Checks

Soft Skills

Analytical SkillsTime ManagementProblem-Solving SkillsCommunication SkillsCross-Functional Collaboration

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft OutlookContract Management SoftwareETMFSharePoint

Industry Keywords

Clinical ResearchPharmaceuticalContract Research OrganizationFDA RegulationsEMA Regulations

About the role

Key responsibilities & impact

Develop, review, and assist with negotiation of Site Agreements with institutions and investigators
Provide oversight and expertise for site contract activities throughout clinical trials
Develop investigator grants, Clinical Trial Agreement templates, and applicable plans
Prepare country contract templates
Draft and send Site Agreements and site-related contracts for negotiation
Provide execution timelines and site negotiation status
Coordinate translation of contract materials when applicable
Review study budgets and costs related to contract negotiation
Negotiate contract language and budgets through finalization and execution
Escalate requests outside preapproved parameters, risks, and non-responsive sites
Add equipment information or appendices to Site Agreements when required
Create donation agreements and termination letters as applicable
Review contracts for completeness and accuracy
Finalize contracts and budgets with sites
Perform quality checks before signature processes
Provide contracts and budgets to regulatory teams for submissions when requested
Liaise with legal, data privacy, study teams, sponsors, sites, investigators, and other stakeholders
Facilitate contract signatures
Distribute executed agreements to sites, eTMF, payment teams, sponsors, and internal SharePoint
Maintain real-time tracking tools
Review TMF structure and oversee Investigator Grants Budgets
Act as lead and subject matter expert on site agreements and related processes
Coordinate master budgets, contract plans, and budget plans
Communicate contracting strategies, timelines, and tracking requirements
Develop mitigation plans, resolve negotiation issues, and contribute to process improvement initiatives
Perform other duties as assigned

Requirements

What you’ll need

3 to 5 years of experience as a Contract Specialist in the clinical research, pharmaceutical, or Contract Research Organization industry
Bachelor's degree or equivalent in Business Administration, Finance, Science, or a related field
Excellent verbal and written English language skills
Proficiency with Microsoft Word, Excel, and Outlook
Knowledge and understanding of International Council for Harmonisation (ICH) and Good Clinical Practice (GCP) Guidelines
Knowledge of local country legislation in the sphere of clinical trials and local regulatory requirements
Advanced contract negotiation skills
Proficiency negotiating complex contract terms with clinical sites and vendors
Understanding of international and local clinical trial regulatory requirements, including FDA, EMA, and ICH-GCP
Proficiency in contract management software and tools
Understanding of budgeting and financial principles related to clinical trial contracts
Basic understanding of legal terminology and contract principles
Strong project management, analytical, time management, and problem-solving skills
Ability to manage multiple site contracts, timelines, risks, and deliverables
Ability to work effectively with cross-functional teams
Ability to handle high volumes of work and perform under pressure

Benefits

Comp & perks

Competitive benefits package depending on location
Inclusive and equitable workplace
Transparent compensation
Pay equity and compensation transparency