Precision Medicine Group · Hungary, Poland, Romania, Serbia, Slovakia
Full time RemotePrecision for Medicine is looking for a Site Contracts and Budget Manager to join our European Team. The position can be fully remote from Poland, Slovakia, Serbia, Romania, or Hungary.
Position Summary:
The primary focus of this role is global clinical trial budget template development. You will be responsible for translating complex clinical trial protocols and study documentation into accurate, comprehensive, and negotiation-ready global/site budget templates across multiple countries. Demonstrated hands-on experience developing investigator/site budget templates for global, sponsor- or CRO-managed clinical trials is required.
The role will also include reviewing, drafting, negotiation and tracking of a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements. You will work closely with Clinical Operations study team and play a key role to ensure deliverables are in alignment with defined study timelines.
Essential functions of the job include but are not limited to:
Global Clinical Trial Budget Template Development β Primary Responsibility:
Review clinical trial protocols, including amendments, SoAs, manuals, and other study documentation to identify all activities with potential site-level cost implications.
Translate protocol requirements into detailed, accurate, and scalable global/site budget templates.
Map procedures and activities to applicable study visits and payment milestones.
Develop per-patient, per-visit, conditional, invoiceable, and one-time study costs.
Identify costs that may not be apparent from the SoA, including site start-up, pharmacy, laboratory, imaging, record retention/archiving, maintenance, close-out, screen failures, unscheduled visits, participant reimbursement/travel, institutional/overhead, and other pass-through or invoiceable fees.
Ensure budget structures support appropriate payment terms and CTA exhibits.
Incorporate approved country-specific cost information and available benchmarks into global and country-level budget templates.
Establish proposed negotiation targets, parameters, and escalation pathways.
Perform detailed QC of budget templates before release to assigned SCM negotiators, including verification of formulas, visit totals, conditional procedures, invoiceable items, and patient-cost calculations.
Confirm consistency between protocol/SoA requirements and completed budgets and clearly document budget assumptions and negotiation parameters.
Maintain version control and an auditable record of budget-development decisions.
Review protocol amendments and revised study documents to identify financial impact and update master/site budget templates accordingly.
Clearly identify added, removed, or modified procedures and associated financial impacts for SCM.
Serve as a budget-development SME for SCM and study teams and clarify budget assumptions and unusual protocol requirements.
Support continuous improvement and standardization of global budget templates, tools, SOPs, work instructions, and training.
Identify opportunities for automation and increased efficiency in clinical trial budget development.
Site Contracts β Secondary Responsibility
Qualifications:
Minimum Required:
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, including substantial hands-on experience developing investigator/site budget templates.
Demonstrated experience developing global and/or multi-country clinical trial budget templates for sponsor- or CRO-managed studies is required.
Strong 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 and/or benchmarking data to develop budget assumptions and negotiation parameters.
Knowledge of CTA budget exhibits, clinical trial payment terms, and site budget negotiation processes.
Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements, Vendor Contracts and Site Budget negotiations.
Experience leading interactions with Study Teams and Sponsors.
Experience with oncology and/or other complex clinical trial protocols.
Preferred:
Bachelors in scientific fields, business administration or equivalent degree
Skills and Competencies:
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