Our client is caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Over 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

Overview:

The Clinical Trial Supply Planning and Execution organization, as part of Clinical Design, Delivery and Analytics, is responsible for influencing clinical trial design and supply chain strategy for molecules and trials in all stages of development. The Clinical Supply Operations Coordinator (CSOC) will work closely with roles in the CTSP&E organization and other Product Delivery functions. The CSOC is responsible for broad technical systems support for critical business processes, bringing critical thinking skills to data analysis and reporting and collaborating seamlessly across the organization to support the portfolio.

Key Responsibilities

Operational Activities

• Execute technical business processes in CTSP&E systems to manage inventory from initial shipments to trial close-out activities, set up and maintain IXRS parameters and manage virtual and physical material movement
• Process clinical site shipments including management of purchase requisitions, stock transport orders and outbound deliveries in SAP, monitoring of overdue requests and material reconciliation/tracking returns as needed
• Coordinate activities related to forecasting and execution of retest dating processes
• Maintain system planning parameters and request setup of bill of materials management
• Manage the CTSP&E portion of the finished goods specification for creation, review and periodic review processes
• Execute technical business processes to manage study-country releases at a batch level and to manage change requests for date changes, order cancellations and inventory reconciliation
• Analyse and report data for shipment trends and master production scheduling, including contributions to Clinical Demand & Operations metrics
• Participate in appropriate change management to manage the business
• Maintain GMP/GCP compliance by following procedures applicable to clinical trial execution
• Resolve issues including data quality, temperature excursions, material needs, shipment receipt and other issues
• Execute CT supply chain activities using MRP/DRP methodologies & processes to achieve operational excellence
• Appropriately escalate from issue identification through resolution within CTSP&E

Create, Promote and Maintain Operational Excellence

• Actively work in partnership with CTSP&E roles to maintain effective relationships and ensuring efficient and compliant processes
• Fostering an environment of integrated teamwork and partnership via shared learning, accountability, influencing others without authority
• Able to use multiple technologies efficiently to participate in meetings and communicate within CTSP&E and across organizations
• Continuously identify and bring forth process improvement initiatives including standardization and/or re-engineering of processes and controls
• Demonstrate excellent project management abilities and strong systems understanding
• Support innovation and process optimization to speed drug development by influencing scenarios around supply strategies
• Analyse and translate data into key strategic inputs and insights to drive decision making
• Work on high level value-add ad hoc projects while continuing to achieve routine goals
• Support organizational changes

Knowledge and Experience

• Bachelor’s degree
• Fluent in English
• Systems experience
• Proven interpersonal and communication skills
• Ability to work independently and within a global multi-cultural team environment
• Strong organizational, collaboration and multitasking capabilities
• Experience of working to tight deadlines and analysing multiple entities
• Flexibility in adapting to a non-routine and fast paced environment
• Strong project management abilities (timeline, scope, budget, risk management)
• Demonstrated problem-solving skilles
• Ability make decisions in the absence of an obvious answer/approach

Additional Preferences

• Knowledge of clinical trial material requirements including GCP and GMP requirements
• Degree in health care, science or supply chain related field
• Experience with SAP and/or Business Objects
• Experience with data or data analytics
• Experience in supply chain and/or inventory management systems planning
• Experience in clinical development
• Licenses or Certifications: such as APICS, Supply Chain Certificate (via MBA or specific university program), PM Certification
• Ability to flex working hours outside of local core hours to support the portfolio across the globe