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Site Contracts and Budget Manager

🔥 2 minutes ago

🌐 Serbia, 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 2 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 from complex clinical trial protocols and study documentation • Review protocols, amendments, Statements of Activities, manuals, and other study documentation for site-level cost implications • Translate protocol requirements into detailed, accurate, scalable global and 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, overhead, pass-through, and invoiceable costs • Ensure budget structures support payment terms and CTA exhibits • Incorporate country-specific cost information and benchmarks into budget templates • Establish negotiation targets, parameters, and escalation pathways • Perform quality control of budget templates before release to site contract negotiators • Confirm protocol/SoA consistency and document budget assumptions and negotiation parameters • Maintain version control and auditable budget-development records • Review protocol amendments for financial impact and update budget templates • Identify and communicate procedure changes and associated financial impacts • Serve as a budget-development subject matter expert for study and site contract management 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 master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements, and other client contracts • Resolve or escalate contractual issues with internal and external stakeholders • Ensure adherence to company policies, procedures, and contracting standards • Update study team members 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 • Identify process improvements and take corrective action

🎯 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

🏖️ Benefits

• Fully remote work arrangement • Regular full-time employment • Virtual work environment • Equal opportunity employment • Reasonable accommodation for the application process

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