Trial Supplies Manager

Job Title: Trial Supplies Manager Contract Length: 6 mos Functional Area Description: Obtain clinical study needs and develop clinical demand forecasts, implement supply plans and manage inventory for finished goods and comparators to fulfill clinical study needs for programs within the R&D portfolio. Summary: Create and maintain supply strategies for all investigational product based on the scientific and regulatory confines of the drug’s development with minimal supervision. Working independently, they will be capable of mentoring others whilst acting as a consultant to others outside of the role. Responsibilities: Collaborates with internal Global Clinical Supply Chain (GCSC) teams and external Customers and Service Providers, including but not limited to Global Drug Development, Pharmaceutical Development, Product Development Quality (PDQ), External Vendors and Medical to ensure all needs are met. Proactively defines, plans, and communicates the clinical supply chain strategy in support of global clinical studies to ensure optimal use and alignment with study and corporate goals. Demonstrates robust knowledge and confidence of GCSC processes when presenting at cross-functional meetings. Responsible for generating and supporting strategies for continuous improvement, both departmental and/or inter-departmental. Influences clinical and development timelines, study design and country selection. Directly responsible for reviewing and providing input to draft clinical protocols, communicating timelines and investigational product strategies to study and cross-functional teams. Develops supply forecasts for clinical studies through evaluation of the clinical development plan and protocol analysis. Monitors inventory and analyzes drug utilization versus forecast taking into account country requirements and logistical timelines. Issues Manufacturing and Packaging/Labeling requests to Clinical Supply Operations (CSO) in alignment with RDSC Master Planning timelines and based on collaboration with Clinical Development team, Chemistry, Manufacturing & Controls (CMC) team and CSO Packaging and Labeling to ensure package design and clinical label for investigational product meet protocol and regulatory requirements. Monitor use date of investigational drug product for assigned protocols. Support use date extension activities, such as generation of Use Date Extension (UDE) memo, and provide feedback to Logistics team to support generation of UDE labels for depots and clinical sites. Ensures timely delivery of quality clinical supplies for all assigned compounds and protocols by collaborating with internal and external sources while taking into account country Regulatory and QP Release requirements. Participates in development, review and approval of Interactive Response Technology (IRT) specifications. Develops investigational product distribution strategies and maintains distribution and supply strategies at depot and site level according to study and IRT requirements. Actively participates in internal Trial Supply Management and Clinical Supply Chain meetings, Study Team meetings, Clinical Supply Matrix Team meetings and any other relevant meetings providing all relevant data and documentation prior to each meeting, highlighting any risks and mitigation strategies. Collaborates with Clinical Supply Strategic Sourcing team to procure commercial drug in alignment with country and clinical study requirements. Attends meetings with vendors and generates purchase requisitions as needed. Actively supports the budget process by maintaining supply and demand estimates for assigned studies in Budget Tool and by regularly reviewing and updating against revised clinical plans. Acts as the main Clinical Supplies contact person for the assigned compound and associated studies, leading communications regarding global supply strategy with study team as appropriate. Supports associated actions stemming from change controls. In collaboration with Compliance, prepare eTMF, CSR appendices and batch listings to support inspection readiness activities. Enters product complaints and deviations in appropriate system and works with PDQ for investigation and resolution. Writing of departmental procedural documents as applicable. Performs other tasks as assigned. Degree Requirements : BA/BS Experience Requirements: Minimum 3 Pharma industry related experience. Minimum 1 years Clinical Supplies/Development with global experience or equivalent experience. An equivalent combination of education and experience may substitute. Key Competency Requirements: Strong knowledge of the global drug development process and global regulatory Requirements. Strong knowledge of forecasting and planning and proficient knowledge of related areas i.e., Manufacturing Packaging & Labeling, IVRS, Logistics, Quality, Stability, etc. Proficient/Strong knowledge of import/export requirements. Proficient/Strong knowledge of IVRS, CTMS systems and other industry technologies. Strong analytical, communication, negotiation and project management skills. Ability to carry out team and individual leadership, foster open communication and teamwork Ability to influence across functional areas and manage internal/external customer conflict resolution. System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.