Sr. Global Clinical Vendor Manager

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

Summary:

The Sr. Global Clinical Vendor Manager supports the Global Head of Clinical Vendor Budget and Contract Management in the creation, organization, and operational structure of vendor management and governance. This role involves overseeing relationships with external vendors who provide clinical trial services (including and not limited to 3rd party vendors and CRO’s), ensuring compliance with contractual obligations, regulatory requirements, company standards, and project timelines. By utilizing key deliverables such as benchmarking, financial standard reports, KPIs, and performance analysis, the Clinical Vendor Manager drives vendor performance and efficiency. This position requires close understanding of the Budget team Business Operations Lead and strong collaboration with internal stakeholders, clinical operations, procurement, legal, and finance teams.

Essential Functions:

•    Support the Global Head of Clinical Vendor Budget and Contract Management in developing and implementing the vendor management and governance framework. Including Vendor Level process map, Risk Categorization Tool, Metrics Framework Catalog, Performance & Metrics Review Process, Vendor Selection Scorecard and Feedback process.
•    Contribute to the strategic planning and execution of vendor management initiatives.
•    Provide insights and recommendations to enhance vendor governance and operational efficiency.

Vendor Management
•    Identify, evaluate, and select vendors for clinical trial services such as CROs, laboratories, and other specialized service providers with key stakeholder collaboration.
•    Negotiate contracts and service agreements with vendors, ensuring alignment with project budgets and timelines.
•    Maintain ongoing relationships with vendors, acting as the primary point of contact for issue resolution and performance management.
•     Conduct regular performance reviews and participate and contribute in CAPA resolutions where applicable to ensure compliance with regulatory requirements and company standards.
  
Project Coordination in coordination with the BOL and COL of each project 
•      Review and Centrally Oversee the day-to-day interactions with vendors to ensure timely delivery of clinical trial services.
•      Monitor vendor performance metrics, risk management and key performance indicators (KPIs) to ensure quality and efficiency.
•      Work with internal project teams to align vendor activities with overall project goals and timelines.
•      Address and resolve escalated discrepancies or issues that arise during clinical trials.

Financial & Contract Management
- Benchmarking:
•    Utilize benchmarking data to evaluate vendor performance against industry standards and identify areas for improvement.
•    Implement best practices and standards derived from benchmarking to enhance vendor performance and efficiency.
- Financial Standard Reports:
•    Analyze financial standard reports to monitor and manage vendor-related expenses.
•    Ensure that financial reporting aligns with contracted terms and project budgets.
- KPIs and Performance Analysis:
•    Establish and monitor KPIs to assess vendor performance, quality, and efficiency. 
•    Train BOL on KPI’s and vendor performance day to day management) 
•    Conduct regular performance analysis to identify trends, address issues, and implement corrective actions.
•    Provide detailed performance reports to senior management, highlighting key insights and recommendations.
•    Monitor and report on vendor-related expenses, identifying opportunities for cost savings and efficiency improvements.
•    In some cased there may be the need for the VM to 
•    Assist in the development and management of clinical trial budgets, including cost projections for vendor services.
•    Assist in the review of vendor invoices and financial resolutions
- Stakeholder Collaboration:
•    Work closely with global business operations clinical operations, procurement, legal, and finance teams to ensure cohesive management of vendor-related activities.
•    Provide regular updates and reports to senior management on vendor performance and project status.
•    Participate in cross-functional team meetings to provide insights and recommendations related to vendor management.
- Regulatory Compliance:
•    Collaborate with the CQC team to ensure adequate vendor attention and resources are available for audits and CAPAs
•    Maintain documentation and records related to vendor management activities for regulatory submissions and inspections.

Requirements:

•    Bachelor’s degree in life sciences, business administration, or a related field; advanced degree preferred.
•    Minimum of 5 years of experience in clinical trial management, with a focus on vendor management.
•    In-depth knowledge of GCP, FDA regulations, and other relevant regulatory requirements.
•    Strong negotiation, contract management, and project management skills.
•    Excellent communication and interpersonal skills, with the ability to build and maintain relationships with external partners and internal stakeholders.
•    Ability to manage multiple projects and priorities in a fast-paced environment.
•    Proficiency in Microsoft Office Suite and clinical trial management systems and analytics tools.
•    Certification in clinical research (e.g., CCRP, ACRP, SOCRA), experience with global clinical trials and managing international vendors, and familiarity with clinical trial technologies all highly preferred.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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