Clinical Supply Manager
Keystone Computer Associates, Inc. is currently searching for a Clinical Supply Manager for a 12 month contract assignment with our client in Wilmington, DE.
Primary Job Responsibilities and Qualifications:
• Manage the supply chain for a portfolio of global clinical studies across all phases within a drug development program.
• Lead cross functional Study Drug Delivery Teams and represent these teams on the R&D Supply Chain Team.
• Work in collaboration with customer functions to influence and manage demand for individual studies, and is responsible for their supply chain deliverables through leadership of the Study Drug Delivery Team.
• Understands and translates clinical study protocol requirements into demand for drug product within a clinical study including requirements for placebo, comparators and rescue / challenge medication.
• Author the drug supply section of Clinical Study Protocol and lead development of master label text.
• Use simulation tools and supply chain expertise to design optimized, lean supply chains for individual studies, defining allocation of contingency stock, IVRS parameters and requirements of drug product. Where possible seek innovative flexible supply chain solutions capable of supporting multiple studies.
• Using this information, develop options for how the supply requirements of individual/groups of clinical studies can be delivered and propose to the Supply Chain Team. This will include sourcing (in or out) and alignment of sourcing activities with customers, detailed plans including timing of investments/cost expenditure (e.g. purchase of comparator product, phased spend at CROs), identification and management of risks.
• Produce a Study Drug Packaging Agreement documenting the agreed sup ply option providing details of the design, set-up and how the supply chain will operate for each study/group of studies.
• Ensure SC input into the design of the random scheme, incl. pack lists and timely provision of these to Delivery or CRO
• Define IVRS user requirements, set up IVRS tool and ensure timely go-live for individual studies. Use IVRS to track recruitment and adjust IVRS parameters to accommodate any changes in study scope and design.
• Collaborate with CRO partners in development of pack design and review the technical part of the outsourcing contract. Review changes to the contract with CRO partners and Sourcing Managers as necessary.
• Establish the supply chain for individual/groups of studies and ensure delivery of the end to end supply of materials to meet study needs Monitor the performance of the supply chain and optimize for higher volume phases of the project, balancing speed, quality and cost with respect to the agreed level of risk.
• Monitor the budget for individual study supply activities and materials for the project.
• Flag deviations to SC Program Manager
• Maintain appropriate information for study supply activities to support updates in OPAL.
• Manage change in demand and supply, resolve issues, escalating when appropriate
• Work with other Study Managers to resolve issues, share best practice and continually develop competence.
• Promote supply chain practice in Pharm Dev and interfacing functions.
• Where appropriate deputize for SC Program Manager on SCT and PD Project Team.
• Represent R&D SC at monitors / investigators meetings and share learning.
Requirements:
Education, Skills and Capabilities:
• BS Degree Science (Biology/Chemistry) or PharmD
• Extensive experience (5+ years) working with clinical supplies
• Significant experience managing and influencing customer demands
• Working knowledge of the Clinical Trial Directive and global regulatory environment impacting the provision of investigational products
• In-depth knowledge of R&D supply chain and drug development process
• In-depth knowledge of Clinical Development processes relevant to the supply of clinical materials
• Project management experience
• Strong influencing, negotiating and problem-solving skills, including across functional, geographical and cultural boundaries
• Demonstrated technical skills and mindset in supply chain management including demand management, supply chain design / optimization and delivery
• Risk identification and management
Company Description:
Keystone Computer Associates is among the top Information Technology staffing companies in the greater Philadelphia area. As a minority business enterprise, keystone has operated profitably and successfully for over 45 years by providing our clients an exceptional blending of technically oriented management and a talented staff. As an aggressive, innovative leader, Keystone provides companies with dynamic solutions that meet and, in most cases, exceed their staffing needs. Our commitment, dedication and responsiveness to customer requirements have made us a clear leader in the staffing industry. |
