Clinical Supply Chain Resume Samples
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Clinical Supply Chain Resume Samples
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JJ
J Jones
Jonathon
Jones
55506 Quigley Islands
San Francisco
CA
+1 (555) 129 4747
55506 Quigley Islands
San Francisco
CA
Phone
p
+1 (555) 129 4747
Experience
Experience
Phoenix, AZ
Clinical Supply Chain Manager
Phoenix, AZ
Thiel, Rutherford and Pagac
Phoenix, AZ
Clinical Supply Chain Manager
- Utilizes an extensive network in the pharmaceutical industry to generate and cultivate leads for the Clinical Supply Optimization Services (CSOS)
- Works with Fisher Clinical Services (FCS) sales to coordinate a full-service approach with prospective clients
- Effectively mentors and coaches associates new to the CSOS role on best practices associated with managing clinical supply chains
- Designs and implements plan to supply study drug to global clinical trials using sound supply chain techniques
- Conduct activities in a safe and efficient manner
- Expertise in clinical trial supply chain management, including managing complex clinical trials globally
- Utilizes an extensive network in the pharmaceutical industry to generate and cultivate leads for the CSOS
Phoenix, AZ
Clinical Supply Chain Manager Ancillary Management
Phoenix, AZ
Flatley LLC
Phoenix, AZ
Clinical Supply Chain Manager Ancillary Management
- Participates on or leads Clinical Ancillary Management project teams to ensure Clinical Ancillary Management services are defined and executed
- Develops and provides client(s) with reports on actual project spend versus budget
- Identifies new CAM and other service line opportunities with existing clients and engages Business Development resources accordingly
- Applies Good Manufacturing Principles in all areas of responsibility
- Establishes and maintains financial forecasts and monthly billing processes for assigned client projects
- Assists in training and on boarding of new employees
- Plans and manages execution of initial supplies and resupplies for assigned studies
present
Chicago, IL
Clinical Supply Chain Manager Senior
Chicago, IL
Swaniawski-Raynor
present
Chicago, IL
Clinical Supply Chain Manager Senior
present
- Provides recommendations on packaging design, distribution and blinding strategy with existing clients
- Performs study close out activities including returned good reconciliation, inventory destruction processing, and file archiving
- Utilizes an extensive network in the pharmaceutical industry to generate and cultivate leads for the Clinical Supply Optimization Service (CSOS)
- Takes lead in developing solutions to solve issues with existing clients and projects
- Works with FCS sales to coordinate a full service approach with prospective clients
- Devises and implements inventory management plans that have complex supply chains
- Identifies, recommends, and leads process improvement initiatives
Education
Education
Bachelor’s Degree
Bachelor’s Degree
Carnegie Mellon University
Bachelor’s Degree
Skills
Skills
- Strong organizational and self-management skills
- Strong analytical skills
- Strong project management skills
- Exemplary computer skills, including high proficiency in Microsoft Excel
- 5-6 years of experience in the clinical supply area
- Exemplary teamwork and interpersonal skills
- Exemplary communication skills
- 5-6 years of experience in the clinical trial supply management area (not logistics)
- Expertise in clinical trial supply chain management, including managing complex clinical trials globally
- This is a remote position and applicants from the United States and Canada will be considered
15 Clinical Supply Chain resume templates
Read our complete resume writing guides
1
Clinical Supply Chain Manager Resume Examples & Samples
- Demonstrates ability to promote the company vision
- Utilizes an extensive network in the pharmaceutical industry to generate and cultivate leads for the Clinical Supply Optimization Services (CSOS)
- Works with Fisher Clinical Services (FCS) sales to coordinate a full-service approach with prospective clients
- Effectively mentors and coaches associates new to the CSOS role on best practices associated with managing clinical supply chains
- Designs and implements plan to supply study drug to global clinical trials using sound supply chain techniques
- Other duties may be assigned to meet the needs of the business
- 5-6 years of experience in the clinical supply area
- Minimum of three years clinical supply experience, either in Logistics and/or Packaging
- Demonstrated experience with multiple global clinical trials
- Expertise in clinical trial supply chain management, including managing complex clinical trials globally
2
Clinical Supply Chain Manager Senior Resume Examples & Samples
- Demonstrates the ability to promote the company vision
- Utilizes an extensive network in the pharmaceutical industry to generate and cultivate leads for the Clinical Supply Optimization Service
- Works with FCS sales to coordinate a full service approach with prospective clients
- Effectively mentors and coaches associates new to the Clinical Supply Optimization role on best practices associated with managing Clinical supply chains
- Devises and implements inventory management plans that have complex supply chains
- Reviews, interprets and implements supply forecast plans from internal or external tools
- Reviews IRT strategy to ensure it supports the strategic supply plans
- Attends relevant client-related meetings and appropriately represent status of the Clinical Supply Chain
- Bachelors degree, or higher, in operations management or science-related field (equivalent work experience may be considered)
- 9-10 years of experience in the clinical supply area
- Certificates: Certified Project Management Professional is preferred. APICS certification (CPIM) also desirable
- Minimum of three (6) years clinical supply experience, either in Logistics and/or Packaging
3
Senior Manager Clinical Supply Chain Optimization Services Resume Examples & Samples
- Serves as a subject matter expert on the Clinical Supply Chain Optimization Services (CSOS) and provides business development support to the commercial team in meetings with existing and potential clients
- Interprets protocols to assess resource requirements for new client opportunities and finalizes pricing for the quoting team
- Manages resource management process and project staffing of CSOS team
- Makes staffing recommendations to Global Director of Clinical Supply Optimization
- Conducts candidate screening process, interviews, and makes hiring decisions
- Gathers and analyzes financial information pertinent to budgeting and forecasting activity for the department
- Identifies improvement opportunities for the CSOS team
- Conducts regular team meetings to assess the status of studies, identify necessary resources, and proactively address issues
- Works with the Global Director to manage priorities of the department
- Responsible for budgetary aspects including personnel expenses, and other related costs
- Develops standards for employee and department performance in partnership with the Global Director of Clinical Supply Chain Optimization
- Provides mentoring and ongoing coaching and development support for team of CSCMs and DSCs in addition to day to day management of assigned personnel
- Administers the Performance Management Development process for Team Leaders, CSCMs, and DSCs including mid- year and year-end performance discussions, on time, per company guidelines
- Holds staff accountable for their ongoing performance, acknowledging exemplary behaviors and implementing progressive discipline, if necessary
- Monitors and tracks training requirements of all direct reports utilizing iComply
- Responsible for the day to day management of assigned CSOS team personnel
- Responsible for maintaining appropriate metrics to ensure business success
- Works with global CSOS leadership to ensure global processes and procedures are developed and followed with global consistency
- Utilizes an extensive network in the pharmaceutical industry to generate and cultivate leads for the growth of the businesses
- Represents and appropriately positions the services for potential clients
- Attends relevant client related meetings and appropriately represents status of the Clinical Supply Chain
- Conducts activities in a safe and efficient manner
- Bachelors degree or higher in operations management or science-related field (equivalent work experience may be considered)
- 6 or more years of experience in the clinical supply area including study planning and supply chain principals
- Experience working with clinical research professionals is desirable
- Travel required (perhaps as much as 30%). International travel may also be required
- Minimum of six (6) years clinical supply chain experience including supply planning and supply chain principals
- Proven people leadership success
4
Clinical Supply Chain Analyst Resume Examples & Samples
- Assemble data and prepare reports for review by line management
- Keep detailed records of findings at all times and provide management with regular updates and suggestions for improvements
- Work with area management and external service providers on determining appropriate KPIs and how best to receive the metrics
- Generate Key Performance Indicators for all Suppliers, CMOs and Third party Logistic providers
- Utilize analytical and quantitative methods to understand, predict, and enhance clinical supply chain processes
- Drive key performance metrics to established levels
- Analyze and monitor performance, identify gaps and other areas needing improvement, and develop recommendations which support Alkermes corporate goals
- Maintain a dashboard of KPIs to monitor and track metrics to measure performance and improve efficiency
- Prepare performance reports for distribution to key stakeholders
- Implement tools that support the longer term strategy for the clinical supply chain through mathematical based optimization, computer algorithms and heuristics
- Continuously support Clinical planning and other functional areas with data extracts and analytical support
- Administrate the Clinical Supply Chain SharePoint site by ensuring user guidelines are being followed
- Develop mechanism for sharing information across the organization and our service providers
- Assist with the implementation of a Clinical Planning Tool then use tool to support the analytics program
- Maintain up-to-date expertise for a broad range of technical, analytical and information systems skills through attendance of user groups, in-house training and outside seminars
- Enhance department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments
- Pursue continuous improvement approach to support optimization of the clinical supply chain
- BS/BA in Operations Research, Supply Chain, Computer Science, Industrial Systems Engineering or scientific discipline. Life sciences industry related experience is an added benefit
- 1-3 years of relevant professional experience in a highly analytical, data intensive and/or strategic role
- Knowledge of advanced analytical software tools, relational databases, and macros, is a plus
- APICS certification (CPIM, CRIM, CSCP) is a plus
- Lean Six Sigma certification or training preferred
5
Senior Manager, Clinical Supply Chain Resume Examples & Samples
- In partnership with key stakeholders from Clinical Operations, Medical, Quality and Regulatory oversee the development of a Clinical Supply Plan that documents the study design, product requirements, and study assumptions e.g. enrollment, target countries, number of sites, etc. for each study included in a Clinical Program
- Oversee the development of the clinical demand forecast on a study and program level and communicate this monthly to the Supply Chain Planning team, as well as key stakeholders e.g. Operations, R&D, Project Management, to ensure seamless coordination of demand and supply
- On an ad hoc basis prepare clinical demand/supply scenarios using different combinations of inputs and assumptions to project both short-term and long-term supply availability
- Establish collaborative relationships with Supply Chain counterparts at alliance Partners to facilitate communication, planning and close cooperation in support of Clinical Program requirements
- Partner with Contract Manufacturing (CMO) team members assigned to the project team to ensure close communication and alignment of Clinical Program requirements with production capacities and timelines
- Proactively identify issues with the potential to impact a clinical study and/or program and engage with key stakeholders to highlight risks and find solutions
- Periodically conduct training sessions for key stakeholders and cross functional team members on clinical supply chain processes and procedures as detailed in the Partnership manual
- Lead continuous improvement projects to drive significant increases in operational efficiency and cost reduction
- MBA and APICS Certification preferred
- Minimum 8-10 yrs. experience in Supply Chain/Clinical Supply Chain
6
Clinical Supply Chain Manager Resume Examples & Samples
- A minimum of 4 years of experience in a clinical supply related role is preferred
- Experience with clinical supply demand management tools is preferred (e.g., tcVisualize, IVRS, SAP)
- Experience with clinical supply pack/label/distribution, inventory management, and supply chain vendors is required
- Experience with clinical trial operations, project management, and pharma/bio research and development is preferred
- General knowledge of GMP principles is preferrred
- Intermediate to advanced software skills (e.g., Microsoft Excel, Powerpoint) is preferred
- Strong planning and cross-functional coordination skills is required
- Strong attention to detail is required
- Exceptional collaboration skills is required
- Excellent written and verbal communication skills is preferred
- Ability to work independently with some coaching is preferred
- Ability to multi-task and manage complexity is preferred
- Ability to work in a high pressure environment is preferred
- Ability to be solution oriented is preferredClinical Supplies
7
Clinical Supply Chain Manager Resume Examples & Samples
- Bachelor’s Degree plus a minimum of 6 years relevant experience or Master’s Degree plus a minimum of 3 years relevant experience is required
- Supply chain certification (e.g. APICS) and/or Lean and sigma is preferred
- Proven track record with of the following: inventory management, supply chain management, or supply planning is required
- Working knowledge of ERP and/or APS is preferred
- Prior experience in a manufacturing/production environment is preferred
- Experience working in the Pharmaceutical, Consumer Goods, or Medical Device industry is preferable
- Candidate is required to demonstrate a deep understanding of the End-to-End Supply Chain Network and ensures team understanding of the drivers impacting the supply network
- Pro-actively identifies the need for scenarios and drives the process of scenario development and evaluation together with team
- Experience with GMP and/or Quality management systems and processes are preferred
- Prior experience working in an international/global environment is required
- Strong analytical skills: Managing complexity and ability to identify process gaps based on data or root cause analysis, ability to predict risk/impact of supply related processes
- Demonstrated ability to work across organizational boundaries in an international environment through influencing, negotiating and partnering
- Ability to communicate complex issues and solutions to different levels of management for effective decision making
- Ability to understand global End-to-End Supply Chain and/or processes and interdependencies to optimize internal and external decision making
- This position will be based out of Malvern, PA, (secondary location is Titusville, NJ), and may require up to 10% domestic and/or international travel.Clinical Supplies
8
Manager Clinical Supply Chain Resume Examples & Samples
- University degree (BA/BS) required
- Minimum 5 – 7 years Supply Chain/Clinical Supply Chain experience
- Experience in pharmaceutical/biotech/medical device a strong plus
- Experience leading projects with broad scope, cross functional nature and impact outside supply chain
- Demonstrated ability to simplify complex operational information and ensure understanding of cross functional partners
- Strong analytical and problem-solving skills required for resolving issues in a complex, highly regulated environment
- Excellent communication skills (verbal, written and presentation) with the ability to effectively communicate information and ideas to diverse audiences
- Capable of working in a fast paced environment, requiring flexibility together with ability to manage multiple tasks and priorities
- Experience with Lean/Six Sigma/Process Excellence tools, training and/or certification preferred
- Ability to embrace change, challenge the status quo and drive improvements to processes and products
- Solid team player with ability to build rapport with team members at all levels of the organization
- Expert knowledge of Excel, as well as extensive experience using it for forecasting, creating demand/supply scenarios, analyzing tradeoffs between business objectives, etc
- Collaboration and Inclusion
- Personal Accountability
- Motivating and Developing
9
Clinical Supply Chain Manager Resume Examples & Samples
- Utilizes an extensive network in the pharmaceutical industry to generate and cultivate leads for the CSOS
- Works with FCS sales to coordinate a full-service approach with prospective clients
- Provides information for Simulation and prepares the summary report for clients
- Bachelor’s degree in a Science related field or equivalent required. Equivalent work experience may be considered
- 5-6 years of experience in the clinical trial supply management area (not logistics)
- Certificates: Certified Project Management Professional is preferred
- Minimum of three years clinical supply chain management experience
10
Associate Director, Clinical Supply Chain Resume Examples & Samples
- Lead and integrate clinical supply chain functions that presently report to department leadership
- Create, review and update the clinical supply requirement plans based on strategic elements/study forecasts from department resources and Clinical Operations for studies and/or programs
- Review clinical trial protocol and understand impact on supply
- Apply simulation tools to drive optimal clinical supply plan as appropriate
- Communicate and update clinical supply requirements on study and program level to upper management and ensure seamless coordination of demand and supply
- Establish metrics and monitor performance
- Manage international distribution and logistics for clinical programs
- Develop supply strategy to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
- Lead manufacturing plans and ensure timely and efficient supply of investigational product for clinical programs
- Achieve operational objectives by providing information and recommendations to strategic plans and Budget reviews
- Prepare and manage program budgets
- Develop strong internal collaboration with stakeholders to ensure customer satisfaction
- Manage third party relationships
- Manage the development of IXRS supply and return strategy and participate in User Acceptance Testing
- Ensure financial Key Performance Indicators (KPIs) and relevant cost saving targets
- Manage direct reports as required
- Identify continuous improvement projects for clinical supply function
- Bachelors in life sciences or business major required, Masters preferred
- Minimum 10 years in life sciences industry related experience, including Project Management, Clinical Supply Management, and/or Clinical Trials Management
- At least 7 years direct experience in clinical supplies environment, including global studies
- Experience in clinical trial supplies required
- Proficient knowledge of Microsoft Excel, PowerPoint and Project software required
11
Clinical Supply Chain Manager Resume Examples & Samples
- Work directly with all key stakeholders to ensure stock at sites
- Ability to pull together a cross-functional team for study management activities
- Bachelor’s degree or equivalent by experience
- 3-5 years industry experience, preferably in Clinical Supplies
- Ability to interpret a clinical protocol and translate into a supply plan
- Ability to forecast work for client accounts
- Full understanding of Project and Supply Chain Management role
- Strong understanding of IRT
- Full understanding of clinical trial phases/designs and how this translates into the entire supply plan
- Full understanding of Annex 13 and GMP regulations and country regulations for clinical trials
12
Clinical Supply Chain Manager Resume Examples & Samples
- Create, review, and update the clinical supply and demand plans based on strategic elements/study forecasts from Clinical Operations for studies and/or programs
- Communicate and update clinical supply requirements on study and program levels to Supply Chain program leads and ensure seamless coordination of demand and supply
- Coordinate US and international distribution and logistics for clinical programs
- Manage label development process
- Develop IXRS and participate in User Acceptance Testing
- Develop packaging and supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
- Prepare program budgets and ensure financial Key Performance Indicators (KPIs) and relevant cost saving targets
- Minimum 5 years in life sciences industry related experience, including Project Management, Pharmaceutical Development, Clinical Supply Management, and/or Clinical Trials Coordination
- At least 4 years direct experience in clinical supplies environment
13
Business Analyst, Clinical Supply Chain Resume Examples & Samples
- Preparing required business intelligence and metrics needs, including but not limited to scorecard submissions, vendor oversight reports, and monthly performance monitoring metrics/KPIs to measure
- Supporting ad hoc requests based on identified reporting needs. Working with business technology teams to evolve reporting
- Providing internal/external customer support and interfacing with IT staff and vendors
- Able to translate need into action with speed and accuracy
- Experience with budget forecasting and financial modeling a plus
- Oversight of external vendor connectivity and data transfers
- Proven ability to negotiate and problem-solve
- Demonstrated ability to apply process improvements and procedures
- Strong documentation and organizational skills
- Able to project and maintain a professional and positive attitude
- Six Sigma certification a plus
- 5+ years' experience with troubleshooting data results
- Advanced/Expert level Microsoft Excel skills including use of macros/advanced formulas
- Considerable knowledge of interdependencies of supply chain principles, practices and concepts and an understanding of the practices, concepts and operations in other relevant disciplines
- Advanced Microsoft SharePoint skills a plus
- Detailed understanding of the Pharmaceutical environment, especially as pertaining to Clinical Study management and related processes preferred
- Familiarity with regulatory requirements related to Clinical Study operations (including GCP, GMP, and GDP) preferred
14
Clinical Supply Chain Manager Ancillary Management Resume Examples & Samples
- Designs and implements strategic plans to forecast and supply ancillary materials to global clinical trials using sound supply chain techniques
- Determines the clinical ancillary materials distribution model including depots, customer affiliates and investigator sites
- Monitors and updates forecasts, tracks usage of clinical ancillary supplies, and monitors inventory levels
- Maintains documents according to guidelines and relevant procedures
- Executes supply chain inventory management processes in partnership with internal Clinical Ancillary Management team members, packaging and distributing partners
- Understands high level import/export requirements for global distribution of clinical ancillary materials and ensures the appropriate distribution personnel are involved to provide guidance and detail import/export requirements, to generate required documentation and to ensure appropriate procedures are in place
- Plans and manages execution of initial supplies and resupplies for assigned studies
- Proactively identifies potential supply chain issues, provides analysis and recommends solutions
- Summarizes data, prepares presentations and makes recommendations for actions relative to the ancillary supply chain and packaging plans
- Develops and provides client(s) with reports on actual project spend versus budget
- Participates on or leads Clinical Ancillary Management project teams to ensure Clinical Ancillary Management services are defined and executed
- Works with both internal and client Project teams to ensure consistent communication of ancillary material supply status. Identifies potential risks, defines and executes risk mitigation plans
- Obtains written approval from the customer to purchase clinical ancillary supplies when the official purchase order and/or signed proposal have not yet been received
- Ensures project specific data is configured and maintained in the appropriate Fisher Clinical Services proprietary systems
- Takes lead in developing solutions to solve issues with existing clients and projects
- Leverages understanding of Fisher resources to propose solutions to clients
- Supports communication of best practice through shared learning sessions, contribution to guidelines and SOPs
- Identifies new CAM and other service line opportunities with existing clients and engages Business Development resources accordingly
- Verifies final project management, procurement, storage and distribution information for the Finance Department prior to invoices being released Develops and administers training on CAM business processes
- Assists in training and on boarding of new employees
- Participates in sales and marketing activities such as teleconferences, customer visits, audits, estimates and proposals with Sales and other Clinical Ancillary Management personnel
15
Associate Clinical Supply Chain Manager Resume Examples & Samples
- Stays abreast of relevant cGMPs, GCPs, and other regulatory requirements and ensures study management activities are aligned
- Utilizes understanding of Clinical Trial Supply Chain Management best practice principles to suggest improvements to exisiting business processes and supports development of associated training material and documentation
- Bachelor’s degree or equivalent required. Degree in operations management or science-related field (equivalent work experience may be considered
- Certificates: Certified Project Management Professional is preferred. APICS certification (CPIM) is also desirable
- Minimum of three years supply chain experiences, either in Logistics, IRT, and/or Packaging
- Demonstrated experience in successfully managing projects in a proactive manner
- Strong organizational and self-management skills
16
Clinical Supply Chain Manager Senior Resume Examples & Samples
- Designs and implements strategic plans to supply study drug to complex global clinical trials using sound supply chain techniques
- Reviews, interprets and implements supply forecast plans from internal or external source documents and tools
- Provides input into user requirement specifications of Interactive Response Technology (IRT) medication management module(s) as needed
- Reviews IRT strategy to ensure it supports the strategic supply plans and ensures that IRT settings are adjusted to optimize the supply chain
- Executes IRT User Acceptance Testing, if required
- Leverages the inventory management capabilities of the IRT to appropriately manage studies
- Executes supply chain inventory management processes in partnership with internal Clinical Supply Optimization Services team members and packaging partners
- Serves as the global project lead on assigned projects, ensuring internal project resources are focused on delivery and client satisfaction, leading by example and negotiating across geographic and functional lines
- Ensures temperature excursion process is executed as required
- Performs study close out activities including returned good reconciliation, inventory destruction processing, and file archiving
- Summarizes data, prepares presentations and makes recommendations for action relative to the clinical supply chain and packaging plans
- Negotiates effectively with clients regarding study plan without damaging relationships
- Provides recommendations on packaging design, distribution and blinding strategy with existing clients
- Develops supply chain strategies for new clinical projects and initiates activities to support strategies agreed with clients
- Works with both internal and client Project teams to ensure consistent communication of clinical trial material supply status. Identifies potential risks, defines and executes risk mitigation plans
- Identifies, recommends, and leads process improvement initiatives
- Identifies new CSOS and other service line opportunities with existing clients and engages Business Development resources accordingly
- Establishes and maintains financial forecasts and monthly billing processes for assigned client projects
- Recognizes contracted scope of services and connects with the appropriate resources for extensions of service
- Develops and administers training on CSOS business processes
- Utilizes an extensive network in the pharmaceutical industry to generate and cultivate leads for the Clinical Supply Optimization Service (CSOS)
- Works with Fisher Clinical Service sales and marketing to coordinate a full service approach with prospective clients, reviewing trends in customer requirements and proposing strategies
- Utilizes understanding of Clinical Trial Supply Chain Management best practice principles to develop new or improve existing business processes and appropriately documents and revises or develops associated training materials
- Effectively mentors and coaches associates new to the Clinical Supply Optimization role on best practices associated with managing clinical supply chains
- Minimum of five (5) years clinical supply chain management experience
- Experienced in building and managing forecasts for clinical supply chains
- Excellent computer skills, including high proficiency with Microsoft Suite including Excel, Word and MS Project as well as the Office 365 environment
- Significant travel (up to 50%) may be required, including international travel
- Ability to independently manage priorities and workday in a remote setting
- Exemplary communication and presentation skills, conceptual skills
- Excellent Teamwork and interpersonal skills
- Exemplary organization and self-management skills
- Ability to manage multiple tasks and respond to change
- Accuracy and attentiveness to details
- Demonstrated strength in leadership and coaching others
- Strong customer service experience
- Ability to identify problems and work toward a solution
- LI-CCG
17
Manager, Clinical Supply Chain Resume Examples & Samples
- Provide key cross-functional supply team leadership whenever necessary to operationalize supply plans and deliver on Global Supply Chain goals. Track and routinely report on progress to manufacturing and distribution plans, monitoring metrics to better understand supply chain performance
- Establish and manage global distribution networks to support clinical trial activity. Maintain strategic alliances with contract partners for transportation, brokerage, storage and distribution. Work globally to leverage and develop consistent, repeatable best distribution practices for group
- Gather and analyze information related to medicinal demand, inventory, production, and/or distribution plans, for programs or product types, from various systems like Oracle, IVRS, planning systems and databases. Continually seek to develop improvements across these systems
- Provide study management guidance to other employees within group
- Maintain solid relationships with stakeholder groups, and act as key escalation point for internal customers and cross-functional partners
- Develop analytical presentations in support of supply chain recommendations to achieve clinical and patient requirements
- Identify, manage and support continuous improvement projects to build scalable capabilities and improve the efficiency of existing processes
- Provide planning/forecasting inputs towards annual budgets, monitoring expense and inventory budget, reconciling variances
- Apply understanding of clinical regulatory environment, as well as packaging and label development
- LI-POT6
- Analytical/Problem Solving - Significant quantitative/problem solving skills are a core requirement of this job, including experience developing complex Excel spreadsheets. Expert ability to convert detailed data into broad scenarios while clearly identifying assumptions and decision points using Microsoft tools like PowerPoint, Project, Visio etc
- Relationship Management - Ability to develop new business relationships, and to nurture partnerships with internal and external stakeholders. Ability to provide key cross-functional team leadership, in order to maintain alignment and to set and meet collaborative operational goals
- Leadership and Communication - Excellent written and verbal communicator with ability to facilitate/articulate recommendations and key decision points to senior management; demonstrated experience reducing complex subjects to key points; ability to develop solid network across company. Ability to develop improvements related to supply chain processes and systems
- Technical - knowledge of clinical development processes and decision points required; experience working on early and late stage development programs a plus. Significant level of comfort with financial analysis in a portfolio management setting and comfortable evaluating and communicating alternatives based on underlying economic/accounting drivers
- Experience working within a cGMP supply chain environment is essential. Experience with GDP regulations a plus. Experience in planning in an MRP-based production environment is a plus. Minimum 8 years of strong business experience in overall planning, demand forecasting/supply planning, supply chain management and/or distribution required
18
Clinical Supply Chain & Value Analysis Region Director Resume Examples & Samples
- 10+ years; clinical background or experience, or a working knowledge in clinical processes (for positions in hospitals and systems which are clinically and organizationally complex) highly preferred
- 8+ years performance improvement consulting experience (clinical and operational (supply and labor)), client management experience, recent practical healthcare or hospital experience required
- 2-4 years of Managerial/Supervisory experience preferred
- A Bachelor's degree (BS, BA) required
- Area of study: Business, engineering, healthcare management or related discipline
- RN highly preferred
19
Lead, Clinical Supply Chain Resume Examples & Samples
- Represent the Clinical Supply Chain on Clinical Study Teams (CST) and provide a high service level to internal stakeholders (e.g. Clinical Operations, Regulatory, Quality, CMC)
- Work with Clinical Operations to understand clinical demand requirements and ensure alignment with study teams to supply plans and timelines
- Create supply and inventory plans and develop production schedules for clinical trial materials
- Monitor schedule adherence of production schedules and make course corrections if needed
- Manage GMP inventory throughout the supply chain, develop inventory reports, manage upcoming expiry, and ensure drug accountability
- Manage the relationship and oversee daily activities for FG label & pack CMOs and distribution vendors
- Responsible for investigation of exceptions to determine root causes, implement CAPAs and drive closure
- Ensure label text and proofs are in accordance with applicable rules, regulations, product specifications, and clinical study protocol(s)
- Coordinate review and approval of labels with stakeholders (e.g. Regulatory, Clinical Operations, CRO) and CMOs
- Support IRT user acceptance testing, develop IRT supply strategy (DNX parameters), and oversee ongoing supply activities in system
- Coordinate and track bulk shipments to CMOs, depots, and vendors. Maintain and track import licenses
- Develop supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
- Lead cross functional projects and process improvements related to drug supply
- Assist in the creation of Standard Operating Procedures
- Partner with senior leadership and staff in Technical Operations to drive effective engagement, planning, decision making, and value thinking
- Lead financial planning and analysis for commercial drug substance, drug product, and finished goods manufacturing, and product distribution
- Member of the Launch Readiness Team - Drive pre-commercial planning and setup of order-to-cash processes and systems to support successful product launch
- Collaborate directly with Third Party Logistics provider (3PL) partner to create and manage the following processes: accounts payable, invoicing, reconciliation, month/quarter/year end closing accounting, and chargeback
- Lead financial planning and analysis for R&D drug substance and drug product to support advancement of clinical and discovery programs
- Partner with others in Finance & Accounting to ensure effective utilization of systems, application of excel models/tools, reporting and information sharing
- Support broader organization through ad hoc projects and analysis
- Bachelor’s degree and 5+ years of experience
- 3PL & Cost Accounting experience required
- Demonstrated strong collaborative and leadership skills and effective in working with cross-functional team members
- Excellent written and oral communication skills and ability to develop and present analyses to senior members of supply chain, tech ops, finance, accounting, and tax
- Ability to work external customers including CMOs, materials providers, and external auditors
- Experience in developing standard cost analysis to aid in contract negotiations with suppliers of materials, capital equipment, and services
- Experience developing robust analyses in support of inventory reserves, including the identification of required reserves and the monitoring of reserves
- Experience with import/export duties and taxes associated with pharmaceutical products
- Related industry experience with commercial and research and development programs
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes
- Strong team player that has a customer service approach and is solution oriented
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
20
Business Analyst Clinical Supply Chain Resume Examples & Samples
- Refreshing and executing reports from defined PowerPivot models to support operational reporting needs for weekly, monthly or quarterly deliverables
- Assembling content into slide decks to facilitate the delivery of metrics
- Capturing and trending clinical supply logistics data. Making recommendations for process improvements based on trend data
- Proficient with large data analytics tools (Crystal Reports, Spotfire) and techniques
- Experience and working knowledge of Clinical Supply Systems including IRT a plus
- Demonstrated ability to manage time and multiple tasks, effectively prioritize responsibilities, and successfully meet deadlines
- Able to handle difficult and stressful situations with professionalism, initiative, logic and good judgment
- Excellent attention to detail and orientation toward meticulous work
- Ability to multi-task, manage personal time and manage multiple priorities
- Advanced SQL and Business Objects
- MS Office suite proficiency
- Understanding of project management concepts
- Able to apply procedures across an extensive range of scenarios which will require strong problem solving and investigation skills
21
Associate Clinical Supply Chain Manager Resume Examples & Samples
- Utilizes understanding of Clinical Trial Supply Chain Management best practice principles to suggest improvements to existing business processes and supports development of associated training material and documentation
- Certified Project Management Professional is preferred
- Strong organisational and self-management skills
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Clinical Supply Chain Manager Resume Examples & Samples
- Applies Good Manufacturing Principles in all areas of responsibility
- Designs and implements strategic plans to forecast and supply study ancillary materials to global clinical trials using sound supply chain techniques
- Generates requests to customers and or purchasing/vendors to resupply quantities of ancillary materials considering overall project quantities and average lead times for receipt and release of said items
- Monitors and analyzes project performance to anticipate problems and obstacles, and collaborates with customers, suppliers, distribution and Clinical Ancillary Management team members to prevent and/or resolve issues
- Understands high level import/export requirements for global distribution of clinical ancillary materials and ensures the appropriate distribution personnel are involved to provide guidance to detailed import/export requirements, to generate documents and to ensure appropriate procedures are in place
- May lead and/or will participate on teams comprised of customers, suppliers, and/or members of Purchasing, IVRS, Distribution and Packaging to review the clinical study protocol requirements and establish a project plan and timeline. Manages the team and/or the project to deliver against the timeline
- Communicates regularly with all stakeholders
- Maintains accurate records and files in accordance with Clinical Ancillary Management Policies & Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Good Clinical Practices (GCPs) and customer requirements
- Verifies final project management, procurement, storage and distribution information for the Finance Department prior to invoices being released
- Effectively mentors and coaches associates new to the CSOS role on best practices associated with managing clinical supply chains Masters the associated internal information systems
- Conducts all activities in a compliant, safe and efficient manner
- Other duties may be assigned to meet business needs
- Bachelor’s degree in a business, scientific or related discipline (equivalent work experience may be considered)
- Minimum of three-five years of relevant clinical trial management experience required, including demonstrated skills and competency in clinical project management tasks
- Project management, including the ability to manage multiple tasks to meet strict deadlines
- Exemplary computer skills (Microsoft Suite), including strong proficiency in Excel and spreadsheet management
- Understanding of regulatory requirements such as GMPs and GCPs
- Ability to work remotely and idependently
- 20% travel
- Ability to collaboration and demonstrate teamwork within and across multiple departments
- Effective information presentation and query response
- Proficiency in personal computer applications (e.g. Microsoft Word, Excel, PowerPoint, Access, Outlook)
- Thorough understanding of the clinical development process and clinical trial supplies