Site Contracts and Budget Manager

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

📋 Description

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

• Analyze protocols, amendments, Statements of Work (SoAs), manuals, and study documents to assess site-level cost implications.

• Convert protocol requirements into precise global/site budget templates.

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

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

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

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

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

• Set negotiation targets, parameters, and escalation pathways.

• Conduct thorough quality control of budget templates prior to distribution to SCM negotiators.

• Verify alignment between protocol/SoA requirements and finalized budgets, documenting any assumptions.

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

• Evaluate the financial implications of protocol amendments and revise budget templates accordingly.

• Act as a subject matter expert in budget development for SCM and study teams.

• Assist in the standardization of templates, tools, SOPs, work instructions, and training materials.

• Identify opportunities for automation and increased efficiency.

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

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

• Ensure compliance with contracting policies, procedures, and standards.

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

• Facilitate timely contract execution and process enhancements.

• Undertake other assigned responsibilities.

⛳️ Requirements

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

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

• Minimum of 5 years of relevant clinical research experience, including significant hands-on experience 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.

• Strong proficiency in interpreting complex protocols, SoAs, amendments, and supporting study documents to translate requirements into comprehensive site-level costs.

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

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

• Proficient in MS Office applications and computer software.

• Capability to work both independently and collaboratively in a virtual environment.

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

• Preferred: Bachelor's degree in scientific fields, business administration, or a related field.

• Preferred: Exceptional organizational and communication skills with a keen attention to detail.

• Preferred: Proven ability to effectively manage relationships with study teams and/or CRAs/Start-up Associates/(S)BSCA to achieve study timelines.

🏝️ Benefits

• Fully remote work arrangement.

• Regular full-time employment.