Working independently or with members of a Clinical Ancillary Management project team, the Clinical Ancillary Supply Chain Manager is responsible to ensure timely availability of clinical study materials and ancillary supplies to Fisher Clinical Services distribution depots, customer affiliates, and/or investigator sites globally. This includes collaborating with customers and internal resources to define requirements, developing plans and timelines, and coordinating and executing project activities
•Applies Good Manufacturing Principles in all areas of responsibility.
•Demonstrates and promotes the company vision
•Designs and implements strategic plans to forecast and supply study ancillary materials to global clinical trials using sound supply chain techniques
• Determines the clinical ancillary materials distribution model including depots, customer affiliates and investigator sites.
•Monitors and updates forecasts, tracks usage of clinical ancillary supplies, and monitors inventory levels.
•Generates requests to customers and or purchasing/vendors to resupply quantities of ancillary materials considering overall project quantities and average lead times for receipt and release of said items.
•Monitors and analyzes project performance to anticipate problems and obstacles, and collaborates with customers, suppliers, distribution and Clinical Ancillary Management team members to prevent and/or resolve issues
•Understands high level import/export requirements for global distribution of clinical ancillary materials and ensures the appropriate distribution personnel are involved to provide guidance to detailed import/export requirements, to generate documents and to ensure appropriate procedures are in place.
•May lead and/or will participate on teams comprised of customers, suppliers, and/or members of Purchasing, IVRS, Distribution and Packaging to review the clinical study protocol requirements and establish a project plan and timeline. Manages the team and/or the project to deliver against the timeline.
•Participates on or leads Clinical Ancillary Management project teams to ensure Clinical Ancillary Management services are defined and executed.
•Communicates regularly with all stakeholders.
•Obtains written approval from the customer to purchase clinical ancillary supplies when the official purchase order and/or signed proposal have not yet been received.
•Ensures project specific data is configured and maintained in the appropriate Fisher Clinical Services proprietary systems.
•Participates in sales and marketing activities such as teleconferences, customer visits, audits, estimates and proposals with Sales and other Clinical Ancillary Management personnel.
•Maintains accurate records and files in accordance with Clinical Ancillary Management Policies & Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Good Clinical Practices (GCPs) and customer requirements.
•Verifies final project management, procurement, storage and distribution information for the Finance Department prior to invoices being released.
•Effectively mentors and coaches associates new to the CSOS role on best practices associated with managing clinical supply chains Masters the associated internal information systems
•Conducts all activities in a compliant, safe and efficient manner.
•Other duties may be assigned to meet business needs.
- Bachelor’s degree in a business, scientific or related discipline (equivalent work experience may be considered)
- Minimum of three-five years of relevant clinical trial management experience required, including demonstrated skills and competency in clinical project management tasks.
- Project management, including the ability to manage multiple tasks to meet strict deadlines.
- Exemplary computer skills (Microsoft Suite), including strong proficiency in Excel and spreadsheet management
- Understanding of regulatory requirements such as GMPs and GCPs
- Ability to work remotely and idependently
- 20% travel
- Strong customer relationship management skills
- Ability to collaboration and demonstrate teamwork within and across multiple departments.
- Strong verbal and written communication.
- Effective information presentation and query response.
- Strong analytical and problem solving skills
- Proficiency in personal computer applications (e.g. Microsoft Word, Excel, PowerPoint, Access, Outlook).
- Thorough understanding of the clinical development process and clinical trial supplies
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