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Role:Clinical Contracts & Budget Associate
Location: United States – Plano, TX | Maple Grove, MN | Sylmar, CA
Department: Clinical Operations / Clinical Contracting
Employment Type: Full-Time
Position Summary
The Clinical Contracts & Budget Associate provides technical and operational support in the development, negotiation, review, execution, and processing of clinical study and research contracts, amendments, and complex study budgets.
Working under minimal guidance and supervision, the position collaborates with internal and external stakeholders to negotiate routine contractual and financial terms, resolve contract and budget issues, and ensure activities are completed accurately and within established timelines and study milestones.
The role requires an understanding of clinical research operations, business drivers, contractual requirements, compliance obligations, and applicable industry regulations. The incumbent will also support informed consent review, identify potential contractual and budget compliance risks, and provide appropriate guidance to study teams.
Key Responsibilities
- Develop, review, negotiate, and process clinical study contracts, amendments, agreements, and complex clinical trial budgets with research sites and external partners.
- Conduct routine contract and budget negotiations with limited supervision.
- Collaborate with Clinical Operations, Legal, Finance, Procurement, and external site partners to resolve contract and budget issues.
- Ensure contract and budget activities are completed within established timelines, metrics, and study milestones.
- Review informed consent documents for alignment with clinical contracts and agreements and provide guidance to study teams.
- Review and redline contractual documents in accordance with company policies, procedures, and established precedents.
- Identify potential contractual, financial, and compliance risks and support timely risk mitigation.
- Ensure required site and study information is complete and maintained to support regulatory and government requirements.
- Support compliance with Google Cloud Platform, ICH, GLP, applicable federal and state regulations, company policies, and industry standards.
- Maintain accurate contract, budget, and study documentation in applicable systems.
- Provide timely follow-up on outstanding contract and budget activities.
- Escalate complex contractual, financial, or compliance matters to appropriate stakeholders.
- Handle sensitive and confidential information with appropriate discretion.
- Support continuous improvement of clinical contracting and budget processes.
Required Qualifications
- Associate degree or equivalent combination of education and relevant experience.
- Minimum 1–2 years of relevant experience in clinical research, clinical contracting, contract administration, budgeting, legal operations, or a related field.
- Strong written and verbal communication skills.
- Strong analytical, organizational, problem-solving, and follow-up skills.
- Ability to manage multiple priorities and meet deadlines.
- Proficiency with Microsoft Word and Excel.
Preferred Qualifications
- Bachelor's degree in Business Administration, Life Sciences, Healthcare Administration, Legal Studies, or a related field.
- 3–5 years of experience in clinical contracts, clinical trial budgets, contract administration, or a related function.
- Experience in a pharmaceutical, biotechnology, medical device, CRO, or other life sciences organization.
- Sponsor-side clinical contracting experience preferred.
- Paralegal certificate or relevant legal/contract training preferred.
- Experience negotiating and redlining clinical trial agreements and site budgets.
- Knowledge of contract law and fundamental legal terminology.
- Familiarity with clinical research regulations and industry standards, including Google Cloud Platform, ICH, GLP, Sunshine Act/Open Payments, FWA, Human Subject Protection, and clinical trial insurance requirements.
- Experience working with cross-functional teams and external research sites.
Core Competencies
- Clinical Contracting & Budget Negotiation
- Contract Review & Redlining
- Clinical Research Compliance
- Risk Identification & Mitigation
- Stakeholder Management
- Analytical & Problem-Solving Skills
- Written & Verbal Communication
- Organization & Time Management
- Attention to Detail
- Confidentiality & Professional Judgment
Work Locations
- Plano, Texas
- Maple Grove, Minnesota
- Sylmar, California
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