Site Contracts and Budget Manager

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

📋 Description

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

• Analyze protocols, amendments, Statements of Activities, manuals, and other study materials for their financial implications at the site level.

• Convert protocol requirements into precise, scalable global and site-specific budget templates.

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

• Develop costs associated with each patient, visit, conditional expenses, invoiceable items, and one-time study expenditures.

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

• Ensure budget frameworks accommodate payment terms and CTA exhibits.

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

• Set negotiation benchmarks, parameters, and escalation routes.

• Conduct quality assurance on budget templates prior to distribution to site contract negotiators.

• Verify the consistency of protocol/SoA and document budget assumptions and negotiation parameters.

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

• Assess protocol amendments for financial consequences and revise budget templates accordingly.

• Identify and communicate changes in procedures and their financial impacts.

• Act as a budget-development expert for study and site contract management teams.

• Facilitate enhancements and standardization of budget templates, tools, SOPs, work instructions, and training programs.

• Identify opportunities for automation and efficiency in budget development processes.

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

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

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

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

• Establish, monitor, report, and manage site contract metrics.

• Maintain contract files and databases, including the archiving of contracts.

• Assist in creating policies and procedures that support prompt contract execution.

• Recognize areas for process improvement and implement corrective actions.

⛳️ Requirements

• Bachelor’s degree, postgraduate degree, or a four-year college degree.

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

• A minimum of 5 years of relevant clinical research experience, including significant hands-on involvement 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 capacity to interpret complex protocols, SoAs, amendments, and related study documents, translating requirements into comprehensive site-level costs.

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

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

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

• Experience in leading interactions with Study Teams and Sponsors.

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

• Proficiency in MS Office software and computer applications.

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

🏝️ Benefits

• Fully remote work arrangement.

• Regular full-time employment.

• Virtual work environment.

• Equal opportunity employment.

• Reasonable accommodation during the application process.