TalentBurst
Title: Senior Clinical Supply Chain Planner
Location: Cambridge, MA (Hybrid)
Duration: 06+ months contract (+Possibility of extension)
Hybrid: Starting will be 3 days onsite Tues-Thurs; once they are up to speed can be Tues and Weds.
Overview The Clinical Supply Chain Planner is responsible for the management and oversight of end to end clinical supply chain activity for assigned clinical protocols. This position works closely with key stakeholders including Clinical Operations, Global Planning, Quality Assurance, Regulatory Affairs, Contract Manufacturing Operations (CMOs), and Contract Research Organizations (CROs) to ensure seamless supply of Clinical Trial Material. Some key areas of management/oversight include forecasting, packaging, labeling, distribution, inventory management, financial planning/budgeting, vendor oversight, and eTMF filing of Clinical Supply documents. A successful candidate will be skilled at understanding the Clinical Supply needs and responsibilities, exhibit strong attention to detail, support a collaborative environment with a strong communication skillset, and the ability to prioritize workload and meet project timelines.
Summary of Key Responsibilities
Managing packaging, labeling, and distribution of clinical trial material for global clinical trials
Support (Interactive Response Technology) IRT development, user acceptance testing (UAT), and system oversight, as well as utilize the system to actively manage clinical trial material.
Utilize and support the management and use of home-grown budget forecasting and planning tool
Partner with Clinical Operations to align on demand assumptions
Develop supply strategies to maximize supply efficiency and minimize waste
Design and actively manage supply & demand forecasts in our web-based optimization tool
Identify potential supply risks, and develop risk mitigation plans as necessary
Drive label creation and approval process, including translations and regulatory requirements
Communicate clinical supply requirements to Global Planning and ensure seamless coordination of demand and supply
Support return and destruction of clinical trial material for assigned protocols
Manage program and/or protocol budget, monitor KPIs, and strive to achieve relevant cost saving targets
Maintain collaborative relationships with third party vendors to assure the complete scope of planning activities remains connected with operations and compliant with quality requirements
Qualifications
BS degree in Life Sciences or Supply Chain Management
Experience: Minimum 3+ years of experience in clinical supply
Understanding of end to end clinical supply chain activity
Experience with supply/demand forecasting systems a plus (eg. NSIDE, Bioclinica, 4G, Oracle, etc)
Experience with IRT systems
Strong understanding of GxP
Proficient knowledge of MS Office (Excel, PowerPoint, Visio, Project, etc)
Demonstrated flexibility to adapt to external environment influences through identifying new strategies and tactics
Strong attention to detail
Excellent communication, collaboration, and influencing skills
Ability to multi-task and manage complex challenges
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Location: Cambridge, MA (Hybrid)
Duration: 06+ months contract (+Possibility of extension)
Hybrid: Starting will be 3 days onsite Tues-Thurs; once they are up to speed can be Tues and Weds.
Overview The Clinical Supply Chain Planner is responsible for the management and oversight of end to end clinical supply chain activity for assigned clinical protocols. This position works closely with key stakeholders including Clinical Operations, Global Planning, Quality Assurance, Regulatory Affairs, Contract Manufacturing Operations (CMOs), and Contract Research Organizations (CROs) to ensure seamless supply of Clinical Trial Material. Some key areas of management/oversight include forecasting, packaging, labeling, distribution, inventory management, financial planning/budgeting, vendor oversight, and eTMF filing of Clinical Supply documents. A successful candidate will be skilled at understanding the Clinical Supply needs and responsibilities, exhibit strong attention to detail, support a collaborative environment with a strong communication skillset, and the ability to prioritize workload and meet project timelines.
Summary of Key Responsibilities
Managing packaging, labeling, and distribution of clinical trial material for global clinical trials
Support (Interactive Response Technology) IRT development, user acceptance testing (UAT), and system oversight, as well as utilize the system to actively manage clinical trial material.
Utilize and support the management and use of home-grown budget forecasting and planning tool
Partner with Clinical Operations to align on demand assumptions
Develop supply strategies to maximize supply efficiency and minimize waste
Design and actively manage supply & demand forecasts in our web-based optimization tool
Identify potential supply risks, and develop risk mitigation plans as necessary
Drive label creation and approval process, including translations and regulatory requirements
Communicate clinical supply requirements to Global Planning and ensure seamless coordination of demand and supply
Support return and destruction of clinical trial material for assigned protocols
Manage program and/or protocol budget, monitor KPIs, and strive to achieve relevant cost saving targets
Maintain collaborative relationships with third party vendors to assure the complete scope of planning activities remains connected with operations and compliant with quality requirements
Qualifications
BS degree in Life Sciences or Supply Chain Management
Experience: Minimum 3+ years of experience in clinical supply
Understanding of end to end clinical supply chain activity
Experience with supply/demand forecasting systems a plus (eg. NSIDE, Bioclinica, 4G, Oracle, etc)
Experience with IRT systems
Strong understanding of GxP
Proficient knowledge of MS Office (Excel, PowerPoint, Visio, Project, etc)
Demonstrated flexibility to adapt to external environment influences through identifying new strategies and tactics
Strong attention to detail
Excellent communication, collaboration, and influencing skills
Ability to multi-task and manage complex challenges
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