Site Contracts Manager, Budget

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

📋 Description

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

• Analyze protocols, amendments, Statements of Activities, manuals, and study materials to determine site-level cost implications.

• Convert protocol specifications into precise, comprehensive, 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 studies.

• 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 items.

• Ensure budget frameworks comply with payment terms and CTA exhibits.

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

• Set negotiation targets, parameters, and escalation pathways.

• Conduct quality control on budget templates, including formulas, visit totals, conditional procedures, invoiceable items, and patient-cost calculations.

• Maintain version control and records that are auditable for budget development.

• Review amendments and updated study documents, adjusting budget templates for financial impact.

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

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

• Identify opportunities for automation and efficiency in budget development.

• Review, draft, negotiate, and monitor master services, site, consulting, vendor, confidentiality, client, and amendment agreements.

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

• Ensure adherence to company contracting policies, procedures, and standards.

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

• Facilitate timely contract execution and process enhancements.

• Collaborate with Clinical Operations study teams to ensure deliverables align with study timelines.

⛳️ Requirements

• Bachelor’s degree or higher, or a 4-year college degree.

• Experience in a CRO, pharmaceutical, biotechnology, or healthcare setting.

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

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

• Strong capability to interpret complex protocols, SoAs, amendments, and related study documents, translating them into complete site-level cost structures.

• Familiarity with country-specific cost data and/or benchmarking information to formulate budget assumptions and negotiation strategies.

• 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 intricate clinical trial protocols.

• Proficient in MS Office software and computer applications.

• Excellent organizational and written communication skills; capable of multitasking and prioritizing in a dynamic environment.

• Ability to manage time-sensitive tasks accurately and independently.

• Ability to collaborate effectively in a virtual environment.

• Must possess legal authorization to work in the country of employment without employer sponsorship.

🏝️ Benefits

• Fully remote work setup.

• Regular full-time employment status.

• Opportunity to work in a virtual setting.

• Commitment to equal opportunity employment.

• Reasonable accommodation support available for applicants with disabilities.