Clinical Contracts Manager - San Mateo, United States - Collabera

Description

Candidate can be based in either Foster City, CA or NJ or Santa Monica locations

Core Responsibilities:

Delivery Excellence:

• Develop a comprehensive global clinical development vendor strategy for Cell Therapy programs or therapeutic areas.
• Lead contract and sourcing activities for Phase 1b-3 clinical development programs, ensuring consistent customer service and delivering quantitative value through cost savings and innovation.
• Implement sourcing strategies and oversee the entire contract negotiation process to maximize contract value and achieve target savings.
• Ensure compliance in the vendor selection process, collaborating with cross-functional teams such as Compliance, Legal, and Regulatory.
• Collaborate with internal stakeholders in vendor bidding, proposal development, and study specification development.
• Serve as a subject matter expert in resolving complex issues related to contract negotiation and management.
• Manage the identification, selection, and management of global external service providers.
• Lead vendor bid defense meetings and manage contract negotiation process for complex or high-value contracts.
• Demonstrate a strong understanding of regulatory and legal issues pertinent to clinical development.

Strategic Thinking:

• Analyze multiple complex sources to develop recommendations from financial and operational perspectives.
• Influence vendor selection with stakeholders at the project team level.

Innovation:

• Identify, develop, and deploy best practices in vendor selection, cost containment, and category management practices.
• Utilize prior experience with external benchmarking, industry best practices, and technology for continuous improvement.

Problem Solving:

• Take ownership of issues from problem identification to successful resolution, triaging study-level vendor management issues and escalating high-risk issues.
• Develop sustainable solutions to operational and systematic issues to ensure study start-up proceeds smoothly.

Influence and Partnership:

• Engage with clinical operations leadership to drive sourcing strategy, compliance, and partnership.
• Establish relationships with internal and external cross-functional teams, collaborating with clinical operations, legal, finance, and compliance.
• Manage study-level vendor relationships in conjunction with Clinical Operations.

Decision Making:

• Develop business solutions by translating requirements into effective sourcing solutions, contractual terms, and process improvements.
• Make critical decisions related to clinical vendor agreement negotiations and escalations.
• Recommend global development vendors to senior leadership for endorsement for a project.
• Resolve vendor project management issues and escalate as needed.

Communication:

• Demonstrate excellent communication skills, interacting with internal and external teams across all levels.
• Train internal stakeholders in contract budgeting, development, and administration as necessary.

Capabilities and Requirements:

• Experience providing thought leadership and consistent customer service.
• Expertise in the end-to-end sourcing and contracting process, including RFx, contract negotiation, and management.
• In-depth knowledge of the clinical research process and regulatory environment across functions.
• Demonstrated leadership skills in a fast-paced and changing environment.
• Financial acumen to review, analyze, and understand cost drivers of complex budgets.
• Legal, clinical operations, and regulatory acumen.
• Travel may be required.

Knowledge, Experience, and Skills:

• Relevant experience with a BA or MS in a relevant discipline.
• MBA or JD preferred.
• PMP/CPSM certification or equivalent a plus.