Site Contracts and Budget Manager

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

📋 Description

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

• Convert protocol specifications into precise, thorough, and negotiation-ready budget templates for global and site-specific use across various countries.

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

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

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

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

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

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

• Define negotiation targets, parameters, and escalation pathways.

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

• Verify consistency between protocol/SoA requirements and finalized budgets, documenting all assumptions.

• Maintain version control and records of budget development that can be audited.

• Revise budgets in response to protocol amendments and updated study documents.

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

• Assist in the standardization of budget templates, tools, Standard Operating Procedures (SOPs), work instructions, and training materials.

• Identify opportunities for automation and improved efficiency.

• Review, draft, negotiate, and monitor clinical trial agreements, site contracts, vendor agreements, consulting contracts, confidentiality agreements, and client contracts.

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

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

• Update study team members regarding the status of contract negotiation and execution.

• Support policies and procedures to ensure timely contract execution.

⛳️ Requirements

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

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

• A minimum of 5 years of relevant clinical research experience, including 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 requirements into comprehensive site-level costs.

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

• Understanding 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 in leading interactions with Study Teams and Sponsors.

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

• Proficient in Microsoft Office software and various computer applications.

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

🏝️ Benefits

• Fully remote work arrangement.

• Virtual work environment.

• Equal opportunity employment.

• Reasonable accommodation for applicants with disabilities.