BioSpace, Inc.
Manager - Clinical Trial Management
BioSpace, Inc., Indianapolis, Indiana, us, 46262
Job Details
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Main Purpose and Objectives of Position:
The Clinical Supply Planning and Execution (CSP&E) function is accountable for partnering with drug development teams, clinical, PRD, and the broader Product Delivery Organization to enable innovative supply chain solutions and speed the delivery of clinical trial materials for patients. This is accomplished by planning and scheduling via a Material Requirements Planning (MRP) system (SAP) and communications with key business partners.
The Clinical Trial Supply Management Associate (CTSMA) is responsible for collaborating with the Product Delivery Supply Advisor, Clinical Trial Supply Managers, Molecule Planners and the broader Product Delivery organization to support supply chain planning and execution for all molecules and trials in development. The CTSMA is responsible for developing demand forecasts and inventory management strategies at hubs, depots, and sites then carrying out the strategy alongside supply planning staff and cross-functional operational teams across trials or subsets of trials as assigned. This role will collaborate with their clinical and functional counterparts to develop different supply and execution scenarios that meet trial intent while looking for efficiencies and speed.
The clinical demand forecast and inventory management strategies developed by the CTSMA drives planning and execution activities across Product Delivery, other functions, and internal and external manufacturing, packaging, and distribution plants around the globe.
Key Responsibilities:Collaborate with Product Delivery Supply Advisors, Clinical Trial Supply Managers, and Molecule Planners to provide expertise in supply chain methodologies while continually looking for internal and external advancements to grow technical expertise and drive processes improvements for productivity and efficiency gains.Be an active and engaged member of the global trial development team providing expertise around all aspects of clinical supply.Ensure adequate and on time supply of Clinical Trial (CT) Material to support CT execution.As assigned, translate protocol or planned protocol requirements into demand forecast:Determine appropriate operating model for forecasting and calculate the forecast with appropriate business-approved tools and processes. Ensure alignment on modeling with Product Delivery Supply Advisor.Manage accurate CT Material demand forecast via MRP System (SAP) per business processes.Regularly re-evaluate the demand forecast to align with CD&OPAs assigned, use forecasting techniques and site inventory management tools to ensure CT Material supply at sites, hubs, and depos throughout the life of a trial:Coordinate initial shipment strategy and execution to clinical sites.Use systems and tools to maintain proper inventory levels and a reliable shipment forecast.Perform trial-level risk assessments on CT Material quantities and expiry dates throughout life of trial.Calculate and re-assesses quantities for trial-level import permits, as necessary.Create and deliver appropriate training and pharmacy manual creation as it related to CT material and supply.Maintain GMP/GCP compliance by following procedures applicable to CT execution.Communicate with affiliates, worldwide team members, and external partners on timing for CT Material shipments and material availability.Problem solve CT Material issues along with Supply Advisor, Clinical Trial Managers, and Molecule Planners including temperature excursions, material needs, shipment receipt and other issues.Create, review, and/or approve appropriate documents outlined in business processes.Appropriately advance from issue identification through solution within Product Delivery and to the clinical function as it relates to CT supply and execution.Understand how supply strategy and demand forecasts impact Product Delivery and Business Unit/Research budgets and proactively manage communication around budget and changes that impact the budget.Provide information, as requested, for budget development and/or changes to an existing budget as they relate the demand forecast or supply strategy.Reach across boundaries and integrate information from external and internal collaborators to bring together diverse perspectives for supply plans.Support innovation and process optimization to speed drug development by influencing scenarios around supply strategies.Fostering an environment of integrated teamwork via shared learning, accountability, influencing others without authority.Basic Requirements:
Bachelor's degree, preferably in health care or sciences related fieldAdditional Preferences:
3+ years of work experience in supply chain management or clinical development.Strong project management abilities (timeline, scope, budget, risk management)Demonstrated problem solving, attention to detail and result oriented behaviors in a fast-paced environment.Strong communication skillsStrong computer skill (i.e. Word, Excel, PowerPoint, Microsoft Project, other)Passionate about improving technological solutions using new and emerging technologiesAbility to balance multiple activities, prioritize and manage ambiguityDemonstrated exemplary teamwork/interpersonal skillsKnowledge of CT material requirements including GCP and GMP requirementsLicenses or Certifications: such as APICS, Supply Chain Certificate (via MBA or specific university program), Project Management Certification or relevant Project Management experienceMust speak and write fluent EnglishAdditional Information:
Domestic and international travel may be required (10%)Work outside of core hours may be required to support the portfolio across the globe
Lilly currently anticipates that the base salary for this position could range from between $63,000-140,800 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
#WeAreLilly
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Main Purpose and Objectives of Position:
The Clinical Supply Planning and Execution (CSP&E) function is accountable for partnering with drug development teams, clinical, PRD, and the broader Product Delivery Organization to enable innovative supply chain solutions and speed the delivery of clinical trial materials for patients. This is accomplished by planning and scheduling via a Material Requirements Planning (MRP) system (SAP) and communications with key business partners.
The Clinical Trial Supply Management Associate (CTSMA) is responsible for collaborating with the Product Delivery Supply Advisor, Clinical Trial Supply Managers, Molecule Planners and the broader Product Delivery organization to support supply chain planning and execution for all molecules and trials in development. The CTSMA is responsible for developing demand forecasts and inventory management strategies at hubs, depots, and sites then carrying out the strategy alongside supply planning staff and cross-functional operational teams across trials or subsets of trials as assigned. This role will collaborate with their clinical and functional counterparts to develop different supply and execution scenarios that meet trial intent while looking for efficiencies and speed.
The clinical demand forecast and inventory management strategies developed by the CTSMA drives planning and execution activities across Product Delivery, other functions, and internal and external manufacturing, packaging, and distribution plants around the globe.
Key Responsibilities:Collaborate with Product Delivery Supply Advisors, Clinical Trial Supply Managers, and Molecule Planners to provide expertise in supply chain methodologies while continually looking for internal and external advancements to grow technical expertise and drive processes improvements for productivity and efficiency gains.Be an active and engaged member of the global trial development team providing expertise around all aspects of clinical supply.Ensure adequate and on time supply of Clinical Trial (CT) Material to support CT execution.As assigned, translate protocol or planned protocol requirements into demand forecast:Determine appropriate operating model for forecasting and calculate the forecast with appropriate business-approved tools and processes. Ensure alignment on modeling with Product Delivery Supply Advisor.Manage accurate CT Material demand forecast via MRP System (SAP) per business processes.Regularly re-evaluate the demand forecast to align with CD&OPAs assigned, use forecasting techniques and site inventory management tools to ensure CT Material supply at sites, hubs, and depos throughout the life of a trial:Coordinate initial shipment strategy and execution to clinical sites.Use systems and tools to maintain proper inventory levels and a reliable shipment forecast.Perform trial-level risk assessments on CT Material quantities and expiry dates throughout life of trial.Calculate and re-assesses quantities for trial-level import permits, as necessary.Create and deliver appropriate training and pharmacy manual creation as it related to CT material and supply.Maintain GMP/GCP compliance by following procedures applicable to CT execution.Communicate with affiliates, worldwide team members, and external partners on timing for CT Material shipments and material availability.Problem solve CT Material issues along with Supply Advisor, Clinical Trial Managers, and Molecule Planners including temperature excursions, material needs, shipment receipt and other issues.Create, review, and/or approve appropriate documents outlined in business processes.Appropriately advance from issue identification through solution within Product Delivery and to the clinical function as it relates to CT supply and execution.Understand how supply strategy and demand forecasts impact Product Delivery and Business Unit/Research budgets and proactively manage communication around budget and changes that impact the budget.Provide information, as requested, for budget development and/or changes to an existing budget as they relate the demand forecast or supply strategy.Reach across boundaries and integrate information from external and internal collaborators to bring together diverse perspectives for supply plans.Support innovation and process optimization to speed drug development by influencing scenarios around supply strategies.Fostering an environment of integrated teamwork via shared learning, accountability, influencing others without authority.Basic Requirements:
Bachelor's degree, preferably in health care or sciences related fieldAdditional Preferences:
3+ years of work experience in supply chain management or clinical development.Strong project management abilities (timeline, scope, budget, risk management)Demonstrated problem solving, attention to detail and result oriented behaviors in a fast-paced environment.Strong communication skillsStrong computer skill (i.e. Word, Excel, PowerPoint, Microsoft Project, other)Passionate about improving technological solutions using new and emerging technologiesAbility to balance multiple activities, prioritize and manage ambiguityDemonstrated exemplary teamwork/interpersonal skillsKnowledge of CT material requirements including GCP and GMP requirementsLicenses or Certifications: such as APICS, Supply Chain Certificate (via MBA or specific university program), Project Management Certification or relevant Project Management experienceMust speak and write fluent EnglishAdditional Information:
Domestic and international travel may be required (10%)Work outside of core hours may be required to support the portfolio across the globe
Lilly currently anticipates that the base salary for this position could range from between $63,000-140,800 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
#WeAreLilly