Site Contracts and Budget Manager

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

📋 Description

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

• Analyze protocols, amendments, SoAs, manuals, and study documents to determine site-level cost impacts.

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

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

• Develop costs related to per-patient, per-visit, conditional, invoiceable, and one-time study expenses.

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

• Ensure budget frameworks are compatible with payment terms and CTA exhibits.

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

• Set negotiation targets, parameters, and escalation pathways.

• Conduct quality control checks on budget templates prior to distribution to SCM negotiators.

• Verify consistency between protocol/SoA requirements and finalized budgets.

• Maintain version control and ensure auditable records of budget development.

• Revise budget templates in accordance with protocol amendments and updated study documents.

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

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

• Identify opportunities for automation and efficiency improvements.

• Review, draft, negotiate, and monitor site, vendor, confidentiality, consulting, master services, 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 contract negotiation and execution status to study team members.

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

• Maintain contract files and databases, including archiving responsibilities.

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

• Identify process enhancements and take corrective actions.

⛳️ Requirements

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

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

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

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

• Ability to interpret intricate protocols, SoAs, amendments, and supporting study documentation, translating requirements into comprehensive site-level costs.

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

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

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

• Proven ability to lead interactions with Study Teams and Sponsors.

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

• Proficiency in MS Office software programs and computer applications.

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

🏝️ Benefits

• Fully remote work arrangement.

• Virtual environment.

• Equal opportunity employment.

• Reasonable accommodations during the application process.