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About the role
Key responsibilities & impact- Responsible for direct site facing contract and budget negotiations through contract execution with assigned clinical investigator sites including initial agreements and amendments
- Manage the Per-Subject Cost (PSC) process for assigned studies
- Manage escalation and resolution for budget and non-legal term issues from other ICL or preferred Contract Research Organizations (pCRO)
- Collaborate with other lines to plan site contracting timelines though start up
- Exercise good judgment in balancing the risks to the sponsor in making budget and contractual decisions against the impacts to client clinical trial timelines
- Follow processes to develop, negotiate, track, and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trials
- Work with partners to develop and oversee the global site budget process
- Work with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters
- Lead study level site contracting activities and act as primary study point of contact for site contracting issues and timelines on assigned studies
- Partner with Legal and other divisions to manage escalations in the site budgeting and contracting space
- Partner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting space
- Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface
- Collaborates with invoicing specialists and/or invoice service provider to ensure alignment with Investigative Site contracting and compensation requirements
- Interacts with clinical site contracts & legal contacts, client and partner legal team, study management, site payments team, peer site contracting colleagues, and CRO site contracting teams
- Contributes to design, development and implementation of major business initiatives or special projects where required
Requirements
What you’ll need- Bachelor’s Degree or equivalent
- 5+ years of experience in clinical development operations or clinical trial outsourcing OR PhD/Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing
- Balance of general business, compliance, finance, legal, and drug development experience
- Precise communications and presentation skills
- Ability to plan, identify and mitigate risks to site contacting timelines
- Ability to lead by influence rather than positional power to accomplish critical deliverables
- Success in working in a highly matrix-based organization
- Fluency in written and spoken English is required
- Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities
- Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation is preferred
Benefits
Comp & perks- Not specified 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
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Hard Skills & Tools
Clinical Study AgreementsBudget ManagementContract ExecutionNegotiation PrinciplesClinical Trial OutsourcingFinancial AnalysisCompliance StandardsContract DraftingClinical DevelopmentSite Management
Soft Skills
Precise CommunicationPresentation SkillsInfluential LeadershipProblem SolvingCollaboration
Certifications
Bachelor’s DegreePhD/Doctorate (Preferred)
