Site Contracts and Budget Manager

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

📋 Description

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

• Convert protocol specifications into precise, adaptable global and site-specific budget templates.

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

• Formulate costs on a per-patient, per-visit basis, along with conditional, invoiceable, and one-time study expenses.

• Recognize costs associated with site initiation, pharmacy, laboratory services, imaging, record retention, maintenance, close-out, screen failure, unscheduled visits, participant reimbursements/travel, institutional/overhead costs, pass-through expenses, and invoiceable charges.

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

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

• Define negotiation targets, parameters, and escalation pathways.

• Conduct rigorous quality control of budget templates prior to their release.

• Maintain consistency between protocol/Statement of Work (SoA) requirements and budgets; document assumptions and negotiation parameters.

• Keep version control and maintain auditable records of budget development.

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

• Act as a subject matter expert in budget development for Supply Chain Management (SCM) and study teams.

• Assist in enhancing and standardizing budget templates, tools, Standard Operating Procedures (SOPs), work instructions, and training materials.

• Identify opportunities for automation and improved efficiency.

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

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

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

• Report on the status of contract negotiations and execution to study team members.

• Establish, monitor, report, and manage metrics related to site contracts.

• Maintain contract files and databases, including archiving duties.

• Support policies and processes for the timely execution of contracts.

• Identify opportunities for process improvements and implement corrective actions.

⛳️ Requirements

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

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

• Minimum of 5 years of pertinent 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 aptitude for interpreting intricate protocols, SoAs, amendments, and supporting study documents and translating those requirements into detailed 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 conditions, 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 complex clinical trial protocols.

• Proficient in MS Office software programs and computer applications.

• Ability to work both independently and collaboratively in a virtual setting.

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

🏝️ Benefits

• Fully remote work arrangement.

• Regular full-time employment.

• Work in a virtual environment.

• Equal opportunity employment.

• Reasonable accommodations available for applicants with disabilities.