Site Contracts and Budget Manager

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

📋 Description

• Primary responsibility is to develop global clinical trial budget templates.

• Review clinical trial protocols, amendments, Statements of Activities, manuals, and study documentation to assess site-level cost implications.

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

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

• Create costs associated with per-patient, per-visit, conditional, invoiceable, and one-time study expenses.

• Identify fees 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 charges.

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

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

• Set negotiation targets, parameters, and escalation processes.

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

• Verify consistency between protocol/SoA requirements and budgets; document assumptions and negotiation parameters.

• Maintain version control and records of the budget development process that are auditable.

• Review protocol amendments and revise master/site budget templates for their financial impacts.

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

• Aid 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 site contracts, confidentiality agreements, master services agreements, consulting agreements, vendor agreements, and other client contracts.

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

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

• Update study teams regarding the status of contract negotiations and executions.

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

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

• Assist in the development of policies and procedures that support timely contract execution.

⛳️ Requirements

• A graduate, postgraduate, or a 4-year college degree is required.

• Experience within a CRO, pharmaceutical, biotechnology, or healthcare environment is necessary.

• At least 5 years of relevant 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 and translate those 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 software programs and computer applications.

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

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

• Preferred: Exceptional organizational and communication skills, along with an eye for detail.

• Preferred: Successful management of relationships with study teams and/or CRAs/Start-up Associate/(S)BSCA to adhere to study timelines.

🏝️ Benefits

• Fully remote work arrangement.

• Virtual work environment.

• Equal opportunity employment.

• Reasonable accommodations available for applicants with disabilities.