Site Contracts and Budget Manager

Precision Medicine Group

Contract type

Ongoing

Work mode

Remote

Experience

Senior · 5+ years

Job description

The Site Contracts and Budget Manager at Precision for Medicine develops global clinical trial site budget templates and negotiates site contracts. The role focuses primarily on translating clinical trial protocols into accurate, negotiation-ready budget templates across multiple countries, with a secondary responsibility for reviewing, drafting and negotiating legal agreements.

At a glance

Employment: Full-time · Employee (employment agreement)
Work mode: Remote

What you'll do

Review clinical trial protocols, including amendments, SoAs, manuals, and other study documentation to identify all activities with potential site-level cost implications
Translate protocol requirements into detailed, accurate, and scalable global/site budget templates
Map procedures and activities to applicable study visits and payment milestones
Develop per-patient, per-visit, conditional, invoiceable, and one-time study costs
Ensure budget structures support appropriate payment terms and CTA exhibits
Incorporate approved country-specific cost information and available benchmarks into global and country-level budget templates
Establish proposed negotiation targets, parameters, and escalation pathways
Perform detailed QC of budget templates before release to assigned SCM negotiators, including verification of formulas, visit totals, conditional procedures, invoiceable items, and patient-cost calculations
Confirm consistency between protocol/SoA requirements and completed budgets and clearly document budget assumptions and negotiation parameters
Maintain version control and an auditable record of budget-development decisions
Review protocol amendments and revised study documents to identify financial impact and update master/site budget templates accordingly
Clearly identify added, removed, or modified procedures and associated financial impacts for SCM
Serve as a budget-development SME for SCM and study teams and clarify budget assumptions and unusual protocol requirements
Support continuous improvement and standardization of global budget templates, tools, SOPs, work instructions, and training
Identify opportunities for automation and increased efficiency in clinical trial budget development
Review, draft and negotiate a variety of agreements including master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements, and other client contracts
Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues
Ensure adherence to company policies, procedures and contracting standards
Update relevant study team members regarding the status of contract negotiations and execution
Establish, track, report and manage site contract metrics
Support the maintenance of contract files and databases, including contract archiving
Assist in designing and implementing policies and procedures to affect the timely execution of contracts
Recognize where processes can be improved and take corrective action

What we're looking for

Graduate, postgraduate, or 4-year college degree
Experience in a CRO, pharmaceutical, biotechnology, or healthcare environment
At least 5 years of relevant clinical research experience, including substantial hands-on experience developing investigator/site budget templates
Demonstrated experience developing global and/or multi-country clinical trial budget templates for sponsor- or CRO-managed studies
Strong ability to interpret complex protocols, SoAs, amendments, and supporting study documents and translate requirements into complete site-level costs
Experience using country-specific cost information and/or benchmarking data to develop 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
Experience with oncology and/or other complex clinical trial protocols
Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment
Executes time-sensitive matters while maintaining accuracy and attention to detail
Exhibits high self-motivation and is able to work and plan independently as well as in a team environment
Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills
Displays sound business judgment and a proactive, independent work style
Proficient in MS Office software programs and computer applications
Handles sensitive issues with discretion
Works well independently and cooperatively with others to achieve common goals in a virtual environment
Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support
Candidates must be legally authorized to work in the country of employment without employer sponsorship

Nice to have

Bachelors in scientific fields, business administration or equivalent degree
Excellent organizational and communication skills and attention to detail
Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines

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