Senior Manager, Clinical Outsourcing

Job Title: Senior Manager, Clinical Outsourcing

Responsibilities:

1.     Vendor Negotiations and Contract Management

• Manages operational aspects of clinical contracts and change orders, including active negotiation of scope of work, payment terms, and budgets.
• Leads negotiations with vendors to secure optimal contract terms, balancing cost-efficiency with project requirements and timelines.
• Develops and reviews Statements of Work (SOWs) to meet necessary scope and quality requirements, ensuring optimal contractual terms and conditions.
• Assists with the development and improvement of templates, including SOWs, Change Orders, and Master Services Agreements, as well as financial tracking and invoicing format/tools.
• Escalates delays and/or concerns promptly and effectively
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2.     Budget and Financial Oversight

• Reviews and evaluates vendor budgets, performing comparison and analysis functions to ensure alignment with project goals.
• Assists with tracking study/project budgets, comparing budgeted vs. actual costs, and identifying variances within contracts and across multiple projects with shared vendor.
• Provides ongoing financial oversight, collaborating with finance and study teams to support budgeting, forecasting, and accrual processes. Including review of invoices for accuracy and consistency.

3.     Cross-Functional Collaboration

• Attends and participates in clinical team meetings to review vendor performance and update project specifications as part of ongoing contractual management and the invoice approval process.
• Acts as a liaison between clinical study teams, finance, legal, and the Vendor Management team to ensure alignment on project timelines, budget expectations, and performance metrics.
• Collaborates closely with study teams to understand project needs, address potential risks, and adjust vendor engagement strategies proactively.

4.     Vendor Relationship and Performance Management

• Builds and maintains strong, collaborative relationships with vendors, ensuring mutual understanding of goals and service expectations.
• Regularly participates in vendor meetings to review performance, resolve issues, and foster long-term, strategic partnerships.
• Contributes to the development of service level metrics and actively ensures vendors meet established service level expectations, using these metrics to drive accountability and continuous improvement.

5.     Risk Mitigation and Compliance

• Evaluates potential risks in vendor partnerships, such as regulatory compliance and service quality, and implements proactive mitigation strategies. Escalates concerns promptly and effectively

6.     Reporting and Metrics

• Rracks performance metrics to evaluate vendor efficiency, service quality, and adherence to project timelines.
• Provides regular reports to senior management on vendor performance, budget status, and any critical issues, offering insights and recommendations for improvement.

Requirements:

• BS/BA required; MS or JD preferred.
• 6+ years in biotech/pharma clinical research industry, with 3-5 years in clinical outsourcing and business operations.
• Strong knowledge of the clinical vendor landscape and experience in budget evaluation, SOW negotiation, and strategic relationship building.
• Comprehensive understanding of the drug development process, budgeting, accruals, and forecasting.
• Excellent communication, interpersonal, and presentation skills for engaging with internal and external stakeholders.
• Problem-solving mindset with a forward-thinking, ethical approach.