Precision for Medicine is looking for a Site Contracts and Budget Manager to join our European Team. The position can be fully remote from Poland, Slovakia, Serbia, Romania, or Hungary.
Position Summary:
The primary focus of this role is global clinical trial budget template development . You will be responsible for translating complex clinical trial protocols and study documentation into accurate, comprehensive, and negotiation-ready global/site budget templates across multiple countries. Demonstrated hands-on experience developing investigator/site budget templates for global, sponsor- or CRO-managed clinical trials is required.
The role will also include reviewing, drafting, negotiation and tracking of a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements. You will work closely with Clinical Operations study team and play a key role to ensure deliverables are in alignment with defined study timelines.
Essential functions of the job include but are not limited to:
Global Clinical Trial Budget Template Development -- Primary Responsibility:
- 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.
- Identify costs that may not be apparent from the SoA, including site start-up, pharmacy, laboratory, imaging, record retention/archiving, maintenance, close-out, screen failures, unscheduled visits, participant reimbursement/travel, institutional/overhead, and other pass-through or invoiceable fees.
- 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.
Site Contracts -- Secondary Responsibility
- 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.
- Other tasks as assigned.
Qualifikationen:
Minimum Required:
- 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 is required.
- 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.
Bevorzugt:
- 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.
Skills and Competencies:
- 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.
