Clinical Contracts Manager

3 weeks ago

San Mateo, United States Collabera Full time

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.

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