Precision 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 – 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 – Secondary Responsibility
- Review, draft and negotiate a variety of agreements including master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements, and other client contracts.
- Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues.
- Ensure adherence to company policies, procedures and contracting standards.
- Update relevant study team members regarding the status of contract negotiations and execution.
- Establish, track, report and manage site contract metrics.
- Support the maintenance of contract files and databases, including contract archiving.
- Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
- Recognize where processes can be improved and take corrective action.
- Other tasks as assigned.
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:
Skills and Competencies:
- Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.
- Executes time-sensitive matters while maintaining accuracy and attention to detail.
- Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
- Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
- Displays sound business judgment and a proactive, independent work style.
- Proficient in MS Office software programs and computer applications
- Handles sensitive issues with discretion.
- Works well independently and cooperatively with others to achieve common goals in a virtual environment.
- Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
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