Site Contracts and Budget Manager

This is a fully remote position, open to applicants in Slovakia, +4 more countries.

📋 Description

• Create global clinical trial budget templates derived from intricate clinical trial protocols and study documentation.

• Convert protocol requirements into comprehensive, precise, and scalable global/site budget templates.

• Align procedures and activities with study visits and payment milestones.

• Develop costs that are per-patient, per-visit, conditional, invoiceable, and one-time for the study.

• Identify costs associated with site start-up, pharmacy, laboratory, imaging, archiving, maintenance, close-out, screen failure, unscheduled visits, participant reimbursement/travel, institutional/overhead, pass-through, and invoiceable expenses.

• Ensure that budget structures align with payment terms and Clinical Trial Agreement (CTA) exhibits.

• Integrate country-specific cost data and benchmarks into budget templates.

• Set negotiation targets, parameters, and escalation pathways.

• Conduct thorough quality control of budget templates prior to release.

• Document budget assumptions and negotiation parameters, uphold version control, and maintain an auditable record of decisions.

• Examine protocol amendments and revise master/site budget templates to reflect financial impacts.

• Act as a budget-development subject matter expert for Supply Chain Management (SCM) and study teams.

• Promote continuous improvement, standardization, automation, tools, Standard Operating Procedures (SOPs), work instructions, and training.

• Review, draft, negotiate, and track clinical, site, vendor, consulting, confidentiality, and other client agreements.

• Address or escalate contractual issues with both internal and external stakeholders.

• Monitor and report on site contract metrics, while maintaining contract files and databases.

• Keep study team members informed about the status of contract negotiations and execution.

⛳️ Requirements

• Bachelor’s degree, postgraduate degree, or equivalent 4-year college education.

• Experience within a Contract Research Organization (CRO), pharmaceutical, biotechnology, or healthcare setting.

• Minimum of 5 years of pertinent clinical research experience, including significant hands-on experience in developing investigator/site budget templates.

• Proven experience in creating global and/or multi-country clinical trial budget templates for studies managed by sponsors or CROs.

• Capability to interpret complex protocols, Statements of Work (SoAs), amendments, and related study documents, translating requirements into complete site-level costs.

• Experience utilizing country-specific cost information or benchmarking data to formulate budget assumptions and negotiation parameters.

• Understanding of CTA budget exhibits, clinical trial payment terms, and site budget negotiation processes.

• Background in drafting, reviewing, and negotiating site Clinical Trial Agreements, Vendor Contracts, and Site Budget negotiations.

• Proficiency in leading interactions with Study Teams and Sponsors.

• Experience with oncology and/or other complex clinical trial protocols.

• Strong proficiency in MS Office software applications and computer programs.

• Candidates must be legally authorized to work in the country of employment without requiring employer sponsorship.

🏝️ Benefits

• Fully remote work arrangement.

• Equal opportunity employment.

• Reasonable accommodation provided during the application process.