Site Contracts and Budget Manager
Description
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.
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.
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Review clinical trial protocols, including amendments, SoAs, manuals, and other study documentation to identify all activities with potential site-level cost implications.
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Translate protocol requirements into detailed, accurate, and scalable global/site budget templates.
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Map procedures and activities to applicable study visits and payment milestones.
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Develop per-patient, per-visit, conditional, invoiceable, and one-time study costs.
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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.
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Ensure budget structures support appropriate payment terms and CTA exhibits.
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Incorporate approved country-specific cost information and available benchmarks into global and country-level budget templates.
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Establish proposed negotiation targets, parameters, and escalation pathways.
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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.
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Confirm consistency between protocol/SoA requirements and completed budgets and clearly document budget assumptions and negotiation parameters.
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Maintain version control and an auditable record of budget-development decisions.
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Review protocol amendments and revised study documents to identify financial impact and update master/site budget templates accordingly.
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Clearly identify added, removed, or modified procedures and associated financial impacts for SCM.
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Serve as a budget-development SME for SCM and study teams and clarify budget assumptions and unusual protocol requirements.
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Support continuous improvement and standardization of global budget templates, tools, SOPs, work instructions, and training.
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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.
- Other tasks as assigned.
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Graduate, postgraduate, or 4-year college degree.
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Experience in a CRO, pharmaceutical, biotechnology, or healthcare environment.
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At least 5 years of relevant clinical research experience, including substantial hands-on experience developing investigator/site budget templates.
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Demonstrated experience developing global and/or multi-country clinical trial budget templates for sponsor- or CRO-managed studies is required.
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Strong ability to interpret complex protocols, SoAs, amendments, and supporting study documents and translate requirements into complete site-level costs.
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Experience using country-specific cost information and/or benchmarking data to develop budget assumptions and negotiation parameters.
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Knowledge of CTA budget exhibits, clinical trial payment terms, and site budget negotiation processes.
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Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements, Vendor Contracts and Site Budget negotiations.
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Experience leading interactions with Study Teams and Sponsors.
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Experience with oncology and/or other complex clinical trial protocols.
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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.
- 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.
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.
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Candidates must be legally authorized to work in the country of employment without employer sponsorship.
Skills
As published by greenhouse · 20 questions
Basics
First Name, Last Name, Email, Phone, Resume/CV, Cover Letter, Location
Short answers (11)
- LinkedIn Profile optional
- What is your desired salary?
- If yes, when and which company? optional
- If yes, when and which company? optional
- If you selected "Other," please specify the type of visa & expiration/renewal date
- Legal Address - Street Address 1
- Legal Address - Street Address 2 optional
- Legal Address - City
- Legal Address - Zip
- How many years of experience regarding development of global and/or multi-country clinical trial budget templates for sponsor- or CRO-managed studies do you bring?
- How many years of experience in development of investigator/site budget templates do you have?
Pick from a list (9)
- Are you authorized to work lawfully in the country/location for which you are applying?
- Will you now or in the future require Precision Medicine Group to commence (sponsor) an immigration case in order to employ you (for example, work visa application or work visa transfer, or other-employment based immigration case)? This is sometimes called "sponsorship" for an employment-based visa status.
- Have you ever worked for Precision Medicine Group or one of its affiliated companies?
- Have you ever interviewed with Precision Medicine Group or an affiliated company?
- Are you currently subject to a Non-Compete or Non-Solicit with your current employer?
- What type of valid work authorization do you currently have in the country/location for which you are applying?
- I certify that the information on this application, my resume and any supporting documentation I provide is complete and accurate to the best of my knowledge. If this application leads to employment, I understand that false or misleading information in my application, resume or interview may result in my release or termination of employment. I authorize the Company or its agents to confirm all statements contained in this application and/or curriculum vitae as it relates to the position I am seeking and to the extent permitted by the laws of the country where the job is located (“Applicable Laws”). I agree to complete any required authorization forms for the background investigation. I authorize and consent to, without reservation, any party or agency contracted by this employer to furnish the above-mentioned information. I hereby release, discharge, and hold harmless, to the extent permitted by Applicable Laws, any party delivering information to the Company or its duly authorized representative pursuant to this authorization from any liability, claims, charges or causes of action which I may have as a result of the delivery or disclosure of the above requested information and all other persons, corporations, or organizations furnishing such information. If hired, I understand that I will be required to provide genuine documentation establishing my identity and eligibility to be legally employed in the country where the job is located. I also understand that the Company employs only individuals who are legally eligible to work in the country where the job is located.
- Legal Address - State
- Legal Address - Country