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Site Contracts and Budget Manager

🔥 21 minutes ago

🌐 Hungary, Poland, +3 more countries – Remote

infoinfo

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

Where this job comes from

Posted on Precision For Medicine's careers page, not through a job board

First seen by Remote Rocketship 21 minutes ago

Logo of Precision For Medicine

Precision For Medicine

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Develop global clinical trial budget templates as the primary responsibility • Review clinical trial protocols, amendments, Statements of Activities, manuals, and study documentation to identify site-level cost implications • Translate protocol requirements into detailed, accurate, scalable global/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 • Identify site start-up, pharmacy, laboratory, imaging, archiving, maintenance, close-out, screen failure, unscheduled visit, participant reimbursement/travel, institutional/overhead, pass-through, and invoiceable fees • Ensure budget structures support payment terms and CTA exhibits • Incorporate country-specific cost information and benchmarks into global and country-level budget templates • Establish negotiation targets, parameters, and escalation pathways • Perform detailed quality control of budget templates before release to SCM negotiators • Confirm consistency between protocol/SoA requirements and budgets; document assumptions and negotiation parameters • Maintain version control and auditable budget-development records • Review protocol amendments and update master/site budget templates for financial impacts • Serve as a budget-development subject matter expert for SCM and study teams • Support improvement and standardization of budget templates, tools, SOPs, work instructions, and training • Identify automation and efficiency opportunities in budget development • Review, draft, negotiate, and track site contracts, confidentiality agreements, master services agreements, consulting agreements, vendor agreements, and other client contracts • Resolve or escalate contractual issues with internal and external stakeholders • Ensure adherence to company contracting policies, procedures, and standards • Update study teams on contract negotiation and execution status • Establish, track, report, and manage site contract metrics • Maintain contract files and databases, including contract archiving • Assist with policies and procedures supporting timely contract execution

🎯 Requirements

• 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 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 • Proficiency in MS Office software programs and computer applications • Candidates must be legally authorized to work in the country of employment without employer sponsorship • Preferred: Bachelor's in scientific fields, business administration, or equivalent degree • Preferred: Excellent organizational and communication skills and attention to detail • Preferred: Successful handling of relationships with study teams and/or CRAs/Start-up Associate/(S)BSCA to meet study timelines

🏖️ Benefits

• Fully remote work arrangement • Virtual work environment • Equal opportunity employment • Reasonable accommodation available for applicants with disabilities

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