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, including substantial hands-on experience developing investigator/site budget templates.
- Required Skills
- MS Office
Requirements
- Graduate, postgraduate, or 4-year college degree.
- Experience in a CRO, pharmaceutical, biotechnology, or healthcare environment.
- At least 5 years of relevant clinical research experience.
- Substantial hands-on experience developing investigator/site budget templates.
- Experience developing global or multi-country clinical trial budget templates for sponsor- or CRO-managed studies.
- Ability to interpret complex protocols, SoAs, amendments, and supporting study documents and translate requirements into complete site-level costs.
- Experience using country-specific cost information or benchmarking data to develop budget assumptions and negotiation parameters.
- Knowledge of CTA budget exhibits, clinical trial payment terms, and site budget negotiation processes.
- Experience drafting, reviewing, and negotiating site Clinical Trial Agreements, vendor contracts, and site budgets.
- Experience leading interactions with study teams and sponsors.
- Proficiency in MS Office software programs and computer applications.
- Oncology or other complex clinical trial protocol experience is preferred.
Responsibilities
- Review protocols, amendments, SoAs, manuals, and study documents to identify activities with site-level cost implications.
- Translate protocol requirements into 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.
- Identify site costs such as start-up, pharmacy, laboratory, imaging, archiving, close-out, screen failures, and participant reimbursement.
- Incorporate country-specific cost information and benchmarks into global and country-level templates.
- Set proposed negotiation targets, parameters, and escalation pathways, and QC budget templates before release.
- Review protocol amendments and update budget templates to reflect financial impacts.
- Review, draft, negotiate, and track site contracts and other agreements.
- Coordinate with study teams and stakeholders to resolve or escalate contractual issues and report negotiation status.
- Maintain contract files, databases, metrics, and budget-development records.
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