Site Contracts and Budget Manager

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

📋 Description

• Create comprehensive global clinical trial budget templates based on intricate clinical trial protocols and study documentation.

• Convert protocol specifications into precise, scalable global/site budget templates.

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

• Generate costs for per-patient, per-visit, conditional, invoiceable, and one-time study expenses.

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

• Ensure that budget structures are compatible with payment terms and CTA exhibits.

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

• Set negotiation objectives, parameters, and escalation pathways.

• Conduct quality control checks on budget templates prior to their release to SCM negotiators.

• Maintain version control and keep auditable records of budget development.

• Review protocol amendments and revise master/site budget templates accordingly.

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

• Promote ongoing improvement and standardization of templates, tools, standard operating procedures (SOPs), work instructions, and training materials.

• Identify opportunities for automation and increased efficiency.

• Review, draft, negotiate, and monitor clinical, vendor, confidentiality, and other contracts.

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

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

• Support the implementation of policies and procedures to ensure timely contract execution.

⛳️ Requirements

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

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

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

• Proven track record in creating global and/or multi-country clinical trial budget templates for sponsor- or CRO-managed studies.

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

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

• Familiarity with 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.

• Proven experience in leading interactions with Study Teams and Sponsors.

• Background in oncology and/or other complex clinical trial protocols is preferred.

• Proficiency in MS Office software programs and other computer applications.

• Candidates must have legal authorization to work in the country of employment without the need for employer sponsorship.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health, dental, and vision insurance plans.

• Opportunities for professional development and career advancement.

• Flexible work schedules and remote working options.

• Supportive and inclusive company culture.