Site Contracts and Budget Manager

The role

The Site Contracts and Budget Manager focuses on global clinical trial budget template development. This person will translate clinical trial protocols into budget templates and manage the review, drafting, and negotiation of various legal agreements.

What you will do

• Review clinical trial protocols and study documentation to identify site-level cost implications.
• Translate protocol requirements into detailed global or site budget templates.
• Map procedures and activities to study visits and payment milestones.
• Develop per-patient, per-visit, conditional, invoiceable, and one-time study costs.
• Perform detailed QC of budget templates before release to negotiators.
• Review protocol amendments to identify financial impact and update templates.
• Review, draft and negotiate agreements including master services agreements, site contracts, and vendor agreements.
• Update 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.

Required qualifications

• 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.
• 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.
• Ability to interpret complex protocols, SoAs, amendments, and supporting study documents.
• Experience using country-specific cost information and/or benchmarking data.
• 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.
• Proficient in MS Office software programs and computer applications.

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

About the company

Precision Medicine Group is an Equal Opportunity Employer.