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Job Description
Project Manager - Protocol (Hybrid)
Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities associated with clinical supplies for their assigned studies, which could vary in complexity. This individual serves as the primary GCS point of contact to stakeholders both internal and external to GCS and serves as the GCS spokesperson at clinical development related meetings (i.e., Clinical Trial Teams) and product development related meetings. The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (i.e. clinical development, CMC, supply chain, & human health), and balancing needs of patients & ensuring stable supply of product.
Primary activities include, but are not limited to:
Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical supply related topics.
Analyzes and anticipates project risks as they relate to clinical supply chain deliverables and prepares, analyses, and/or develops mitigation strategies for review with clinical partners and senior leaders.
Works directly in the SAP system to establish a consolidated, visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).
Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation to support critical CMC activities.
Responsible for authoring the Clinical Supplies section of the study protocol as well as preparation and presentation of the clinical supplies information at Investigator Meetings for assigned protocols.
Support the collection of clinical supply chain metrics and/or participate in critical non-pipeline activities.
Participate in Interactive Voice Response (IVR) System development and User Acceptance Testing (UAT) for assigned studies.
Demonstrates ability to balance strategy with ability for tactical execution and has strong ownership & accountability of assigned work
Make rapid, disciplined decisions.
Demonstrates Ethics & Integrity.
Required Experience and Skills:
Bachelor’s degree in a scientific, business, or related discipline required, MS/MBA preferred.
At least 8 years of experience in project management.
At least 5 years of experience in planning, scheduling, coordination and processing of supply chain activities, or the equivalent.
Fluent in English and Chinese
Knowledge of both early phase and late phase clinical trials as well as associated supply chain
Technical Proficiency: familiarity with supply chain systems and software (e.g. SAP or Oracle) and demand planning principles as well as Microsoft Excel, PowerPoint, and Word
Strong Analytical & Problem Solving Skills: ability to analyze complex data, identify trends, and make data-driven decisions to optimize supply chain processes.
Detail Oriented & Organized: strong attention to detail in managing complex supply chain activities; ability to multitask, prioritize tasks, and meet tight deadlines.
Continuous Improvement Mindset: Proactive approach to identify process inefficiencies, develop solutions, and drive continuous improvement initiatives within the clinical supply planning function.
Proven record in project / portfolio management.
Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) is highly desirable.
Preferred Experience and Skills:
Proficiency in using supply chain management systems and software, including experience with ERP systems (e.g., SAP), demand planning tools, and inventory management systems.
Familiarity with data analytics/visualization software.
Familiarity with Good Manufacturing Practices (GMP) requirements, quality procedures, and Standard Operating Procedure (SOP) execution.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Current Contingent Workers apply
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