Site Contracts and Budget Manager
P
Precision for MedicineClinical research
The position can be fully remote from Poland, Slovakia, Serbia, Romania, or Hungary.Full-TimeManager
Salary not disclosed
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Job Details
- Experience
- At least 5 years of relevant clinical research experience
- Required Skills
- MS Office
Requirements
- Hold a graduate, postgraduate, or four-year college degree.
- Have at least 5 years of relevant clinical research experience.
- Have substantial hands-on experience developing investigator or site budget templates.
- Have experience developing global or multi-country clinical trial budget templates for sponsor- or CRO-managed studies.
- Be able to interpret complex protocols, SoAs, amendments, and supporting study documents and translate them into complete site-level costs.
- Have experience using country-specific cost information or benchmarking data to develop budget assumptions and negotiation parameters.
- Know CTA budget exhibits, clinical trial payment terms, and site budget negotiation processes.
- Have experience drafting, reviewing, and negotiating site Clinical Trial Agreements, vendor contracts, and site budgets.
- Have experience leading interactions with study teams and sponsors.
- Have experience with oncology or other complex clinical trial protocols.
- Be proficient in MS Office software programs and computer applications.
Responsibilities
- Review clinical trial protocols, amendments, SoAs, manuals, and other study documents to identify activities with site-level cost implications.
- Translate protocol requirements into detailed global and site budget templates, mapping procedures to study visits and payment milestones.
- Develop per-patient, per-visit, conditional, invoiceable, and one-time study costs, including applicable site and participant costs.
- Incorporate approved country-specific cost information and benchmarks into global and country-level templates.
- Establish proposed negotiation targets, parameters, and escalation pathways, and document budget assumptions.
- Quality-check budget templates, including formulas, visit totals, conditional procedures, invoiceable items, and patient-cost calculations.
- Review protocol amendments and revised study documents, identify financial impacts, and update budget templates.
- Review, draft, and negotiate site contracts, vendor agreements, consulting agreements, confidentiality agreements, and other contracts.
- Coordinate with study teams, supervisors, and internal and external stakeholders to resolve contractual issues and communicate negotiation status.
- Track and report site contract metrics and support contract file, database, and archive maintenance.
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