Clinical Trial Manager - Contractor

Summary

The Associate Director, Outsourcing and Vendor Governance will play a key role in leading the Vendor Governance function and supporting clinical outsourcing activities for current and future clinical trials. This position is responsible for driving effective vendor governance while also supporting Clinical Outsourcing activities including vendor identification, request for proposal (RFP) processes, vendor selection, contract and budget negotiations, and sound financial stewardship. The role partners closely with Clinical Development teams, Legal, Finance, and other internal stakeholders to address vendor relationship, contract, and business-related matters. This role involves mentoring and managing direct reports and will report to the Senior Director, Outsourcing and Vendor Governance.

Responsibilities

Clinical Outsourcing:

• Independently manage outsourcing activities for Phase I to III clinical trials and Clinical Development functional area projects, including vendor capability assessments, RFP/RFI, selection, contract & budget negotiation, and other related tasks for the full contract life cycle, as follows:
• Negotiate vendor Master Service Agreements, commercial terms, and amendments.
• Responsible for management and negotiation of all global clinical development contract agreements (Work orders, change orders, confidentiality, HCP agreements, subcontractor agreements, and amendments thereto) in support of multiple functions (e.g., Clinical Operations, Regulatory, Clinical Supply, Data Management, etc.).
• Guide project teams through the sourcing process and give appropriate suggestions and advice on the best approach/industry practices.
• Partner with study team members to manage supplier bidding and proposal development (RFP creation and bid analysis). Facilitate and manage supplier bid defense meetings and associated follow-up.
• Lead contract-related communication with clinical vendors. Respond to questions from internal staff regarding budget revisions and contract status. Interact with suppliers on contract terms. Appropriately resolve conflicts and escalate issues.
• Partner with finance and study team members to address financial queries.
• Create new contract provisions and templates, including modification to existing templates in collaboration with internal stakeholders (e.g., Legal and impacted functional area)
• Demonstrate expanded understanding of contractual provision terms to lead contract review and negotiation through internal and external reviews, as follows:
• Identify and manage contract risks. Develops and ensures appropriate mitigation plans risks are communicated to stakeholders.
• Analyze, provide information, and solutions to leadership on complex contract or finance issues.
• Ensure agreements comply with company requirements regarding risk assessment and liability.
• Respond to and resolve complex contract and budget issues in collaboration with appropriate department(s) representatives.
• Master outsourcing systems in compliance with expectations, enter data in a timely manner, and serve as subject matter expert to peers and colleagues for system related questions.
• Serve as subject matter expert for audits and support audit-readiness efforts.
• Manage purchase order process in support of Clinical Development stakeholders and functions.
• Provide supervision, mentoring, and coaching to direct report(s).

Vendor Governance:

• Provide guidance and collaborate with Clinical Development stakeholders to ensure that all relevant vendor governance standards, processes, and tools (e.g., KPIs, governance charters, etc.) current, securing the required level of Arcus oversight, in compliance with Arcus procedures and requirements.
• Provide and lead vendor governance framework, activities, and initiatives, including the development of process documents and tools.
• Drive governance meetings, ensure proactive scheduling, appropriate attendees, clear delineation of roles and responsibilities, and meaningful meeting content.
• Facilitate governance meeting preparation and perform follow-up while maintaining proper tracking and archival of materials in a central repository.
• Collaborate with vendor counterparts and Arcus stakeholders to identify, document, and mitigate vendor relationship level risks.
• Address escalations on vendor performance issues and propose innovative solutions to reduce risks and achieve satisfactory outcomes.
• Seek innovative solutions (technology or process) to advance how Arcus engages vendors.
• Communicate vendor developments (e.g., acquisitions, innovative technology, restructure, etc.) to Arcus stakeholders.

Process improvement:

• Partner with Clinical Development functional leads on developing optimized category/function sourcing strategy, sourcing model, and strengthen relationships with selected, qualified vendors.
• Lead OVG initiatives and department activities (e.g., process refinement, financial analyses, metrics and key performance indicators, spend consolidation, performance productivity, cycle time reduction, audit readiness, etc.).
• Prepare presentations and train resources and providers on core business requirements.

Qualifications

• A B.A./ B.S. is required; MBA is preferred.
• 10+ years of related business/industry experience.
• Experience in clinical outsourcing in pharmaceutical, biotech, academia, or CROs (Clinical Research Organizations) role.
• Experience in vendor selection (including RFI/RFP process), contracting, and budget negotiation.
• Direct or indirect management of vendor governance meetings and processes.
• Experience managing direct reports is preferred but not required.
• Demonstrates:
• In-depth understanding outsourcing activities for Ph I to III clinical trials, audit preparedness, and the related good business practices.
• Expert knowledge of pharmaceutical sourcing/procurement processes, sourcing models, vendor relationship management, governance, and oversight principles.
• Insight on current clinical vendor landscape across different vendor service categories.
• Strong financial acumen.

Knowledge/Skills/Abilities

• Must be an initiative-taker with minimal supervision.
• Exhibit high self-motivation and ability to work and plan independently as well as in a team environment (virtual or in person).
• Work with cross-functional team members and facilitate communication with internal/external stakeholders.
• Excellent organizational and time management skills to accomplish multiple tasks efficiently and effectively in a demanding environment.
• Diligent and detail-focused with ability to expedite quick turn-around.
• Critical thinking, analyze and synthesize information to understand issues, identify alternate options, and support sound decision making.
• Excellent computer skills including advanced knowledge in use of MS Excel, Word, PowerPoint, and Outlook.
• Strong verbal and written communication skills.
• Execute time-sensitive matters while maintaining accuracy and confidentiality.
• High degree of professionalism, punctuality, deliver commitments on-time, understanding of the culture, and positive interactions with others.
• Display sound business judgment and proactive, independent work style.
• Technical aptitude and result driven.
• Exercise independent judgement in methods, techniques, and evaluation of criteria for obtaining results.
• Ability to travel, including overnight stays.

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