Site Contracts and Budget Manager

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

📋 Description

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

• Examine protocols, amendments, Statements of Activities, manuals, and study documents to discern site-level cost implications.

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

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

• Establish per-patient, per-visit, conditional, invoiceable, and one-time study costs.

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

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

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

• Set negotiation targets, parameters, and escalation pathways.

• Conduct quality control on budget templates, including formulas, visit totals, conditional procedures, invoiceable items, and patient-cost calculations.

• Maintain version control and create auditable records of budget-development decisions.

• Revise master/site budgets in light of protocol amendments and identify related financial impacts.

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

• Promote continuous improvement and standardization of templates, tools, SOPs, work instructions, and training.

• Spot automation and efficiency enhancement opportunities in budget development.

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

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

• Ensure adherence to company contracting policies, procedures, and standards.

• Monitor, report, and manage site contract metrics.

• Maintain contract files and databases, including archiving.

• Facilitate timely contract execution and process enhancements.

⛳️ Requirements

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

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

• Minimum of 5 years of pertinent clinical research experience, including significant hands-on expertise 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.

• Ability to interpret complex protocols, SoAs, amendments, and supplementary study documents and convert requirements into comprehensive site-level costs.

• Familiarity with 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 processes.

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

• Proven 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.

• Legally authorized to work in the country of employment without employer sponsorship.

🏝️ Benefits

• Fully remote work arrangement.

• Regular full-time employment.

• Equal opportunity employer.

• Reasonable accommodation available for applicants with disabilities.