Clinical Supply Chain Resume Sample
Erick Aufderhar
54215 Barton Hill,
Boston,
MA
+1 (555) 920 6258
Work Experience
Clinical Supply Chain Manager
02/2016
-
PRESENT
Detroit, MI
- Proactively manage a program of work, supply of medication, and manage risk management activities
- Work as part of a cross-functional team for study management activities
- Implements and follows defined packaging, distribution and IRT plan to supply study drug to global clinical trials using sound supply chain techniques
- Exemplary communication skills, in English
- In the planning phase engage with divisional organizations and clinical teams to ensure trial distribution and return requirements are defined
- Assist in developing inventory and supply demand plans
- Partner with divisional/regional supply chain professionals to integrate clinical device demand into the overall demand planning for the product
- In the preparation phase engage with external groups/vendors to ensure distribution and processes are in place to support on time enrollment within compliance
- Perform device management system testing
Clinical Supply Chain Analyst
10/2013
-
10/2015
Boston, MA
- Partner with other Clinical Supply Chain team members to complete and approve the Device Management plan prior to the start of study enrollment
- In the enrollment phase, engage with internal and external groups to ensure product is distributed in a timely and compliant manner for site start up and replenishment
- Monitor trial performance and assess device inventory position against supply, timeline and product shelf life
- Oversee device accountability to ensure investigational devices are tracked and disposition is monitored
- Collaborate with internal and external groups to track un-used product through the return process
- Complete ongoing device reconciliation activities per defined study requirements
- Support Vendor Management activities with existing or new trials
- Utilize analytical models to generate product demand, supply, and availability analysis during trial planning and/or enrollment
Business Analyst Clinical Supply Chain
09/2010
-
07/2013
Detroit, MI
- Escalate issues and potential risks to CSC management as applicable
- Translate Clinical Development requirements into an actionable global supply plan
- Lead forecasting efforts, including key stakeholder meetings, to ensure the adequacy of supply/re-supply strategies and negotiate resolution of resource conflicts where necessary and actively participate in planning meetings to ensure that project needs, priorities, and timing are understood
- Serve as the primary interface with Clinical Development, Quality, and Regulatory Affairs to ensure coordination of all activities necessary to maintain the forecast and ensure an adequate supply plan
- Resolve logistical conflicts impacting studies and R&D milestones ensuring that supplies are not on the critical path
- Coordinate labeling, packaging, and shipment of packed supplies
- Promptly identify and escalate risks to study timelines or clinical supplies, from a supply chain perspective, to all key stakeholders and internal management
- Utilize systems to effectively manage key product/project activities
Education
Oglethorpe University
2006 - 2010
Bachelor's Degree in Management
Professional Skills
- Proven leadership skills including leading projects with broad scope, cross functional nature and impact outside supply chain
- Demonstrated ability to manage multiple projects and priorities, and have strong data analysis, problem solving, and decision-making ability
- Excellent computer skills, including high proficiency in Microsoft Suite including Excel, Word and MS Project as well as the Office 365 environment
- Strong PC skills, including Excel, Word and Power Point
- Proven experience with forecast planning, clinical labeling, packaging and cold chain distribution
- Experience in the pharmaceutical/clinical research industry; with at least 3 years of relevant clinical supply chain management/work experience
- Operation support experience in the following: Planning, Compliance, Engineering, Regulatory Affairs, and/or Clinical Development
How to write Clinical Supply Chain Resume
Clinical Supply Chain role is responsible for leadership, microsoft, word, training, database, shipping, analysis, manufacturing, design, research.
To write great resume for clinical supply chain job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Supply Chain Resume
The section contact information is important in your clinical supply chain resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Clinical Supply Chain Resume
The section work experience is an essential part of your clinical supply chain resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous clinical supply chain responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular clinical supply chain position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Supply Chain resume experience can include:
- Able to communicate effectively with GPDO functional areas and regulatory agencies
- Performs study closeout activities including returned good reconciliation, inventory destruction processing, and file archiving
- Proven record in process upscaling and downscaling at multinational companies or CROs
- Substantial experience in working with external manufacturing parties
- Experience in project management or supply chain management in logistics or packaging or supply chain management in a related field
- Experience working in the pharmaceutical industry
Education on a Clinical Supply Chain Resume
Make sure to make education a priority on your clinical supply chain resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your clinical supply chain experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Clinical Supply Chain Resume
When listing skills on your clinical supply chain resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical clinical supply chain skills:
- Strong Analytical skills with ability to structure and perform data analysis
- Strong Organization skills to work multiple issues in parallel over time
- Communicate effectively both orally and in writing both with internal and with external vendors and partners
- Demonstrated proficiency with Microsoft Excel and good working knowledge of other MS Office applications
- Good understanding of ICH, cGMP, ISPE and other pertinent manufacturing and engineering guidelines and practices
- Experience and training in chemical proces engineering tools such as Dynochem
List of Typical Experience For a Clinical Supply Chain Resume
1
Experience For Clinical Supply Chain Manager Resume
- Oversee clinical supply activities including planning, labeling, packaging and distribution of Clinical Trial Material (CTM) for multiple projects
- Coordinate CTM shipping and logistics activities including management of shipments of CTM between storage depots and to clinical trial sites
- Aid in the training and development of new Clinical Supplies employees and give guidance for other functional areas
- Coordinate sample shipments for testing
- Review temperature logs for CTM distribution and storage and investigate temperature deviations according to SOP
2
Experience For Lead, Clinical Supply Chain Resume
- Participate in the development of processes, procedures, and guidelines to meet short and long-term goals for clinical supplies
- Maintain the Pharmaceutical Development inventory and stockroom
- Enter data and perform quality review and hard copy storage of Pharmaceutical Development stability data
- Organize and maintain clinical labels
- Manage activities to a set budget
- Interface with Array departments (i.e. Clinical Operations, Regulatory, GMP Quality Assurance, Manufacturing) to interpret CTM needs from study protocols, define packaging and labeling configurations, support regulatory filings, create and maintain CTM documentation according to established procedures
- BA or BS in a Science or Logistics field or equivalent experience in Clinical Supply Chain
3
Experience For Associate Director, Clinical Supply Chain Resume
- Clinical supply chain experience required
- IXRS experience required
- Participate in design and implementation of Interactive Response Technology (IRT) systems for CTM management
- Participate in review, development, and revision of department SOP’s
- Drivers’ license required
- Manage Temperature Excursions
- In partnership with Quintiles Clinical Project Management as well as Clinical Operations, Medical, Quality and Regulatory lead the development of the clinical supply strategy and Clinical Supply Plan which documents the study design, product requirements and study assumptions e.g. enrollment, target countries, number of sites, etc. for assigned Clinical Programs
- Lead the development of the monthly clinical demand forecast on a study and program level for assigned Clinical Programs. Through participation as a joint member of IP Planning, Clinical Study and Ops Strategy teams define clinical supply requirements and upload forecast to the Supply Chain Planning team, as well as key stakeholders to ensure visibility and close coordination of demand and supply
List of Typical Skills For a Clinical Supply Chain Resume
1
Skills For Clinical Supply Chain Manager Resume
- Demonstrated supply chain experiences in clinical trials
- Experienced in working with GxP requirements
- Experienced in working under GxP requirements
- Supply chain experiences, either in Logistics, IRT, and/or Packaging
- Upply chain analyst experience
- SAP or equivalent ERP system experience
- Good knowledge about API development and new product/process introduction
- Experience in the clinical supply area
- 5– 7 years’ clinical supply management or equivalent experience in the pharmaceutical / biopharmaceutical industry
2
Skills For Lead, Clinical Supply Chain Resume
- Reviewing dataset contents and verifying against source applications
- Accountable for the scheduling and timely delivery of packaged clinical trial material, including randomization, packaging and labeling of clinical supplies
- Work actively with Clinical Operation/Study team to help create forecast for each study and program, including enrollment rate
- Determines the clinical ancillary materials distribution model including depots, customer
- Clinical supplies or Clinical Research training required
- Facilitate the retrieval of Import Permits if required; working with Logistics, Regulatory Affairs, CLO and CRO
- Monitor conformance to Clinical Supplies Inventory Management with Interactive Response Technology (IRT) standards
- Manage IRT supply and drug return strategy with CMO and clinical sites
3
Skills For Associate Director, Clinical Supply Chain Resume
- Manages Clinical Supplies inventory for projects assigned by interfacing with contractor to ensure that inventory systems are kept up-to-date and that final product reconciliation is accurately completed
- Interacts with Clinical sites regarding supply needs, storage and return of clinical supplies
- Develop Standard Operating Procedures (SOPs) and guidelines related to inventory management, distribution, transportation, disposition of returned/unused materials
- Manage routine production planning meeting for clinical projects / products
- Ensures that key supply project milestones are met; negotiates and communicates supply plan timelines to internal and external customers and partners
- Proactively drives cross-functional activities. Works with other line functions and external partners to manage complex projects
- Participates as SME for clinical regulatory audits related to supply
- Proven experience handling confidential information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors is essential and required
- Promotes an environment of continuous quality and improvement of processes
4
Skills For Clinical Supply Chain Manager Ancillary Management Resume
- Development of SQL queries to output defined datasets
- Monitors and analyzes project performance to anticipate problems and obstacles, and
- Excellent leadership skills, strong sense of vision, communication and presentation skills in order to convey goals, objectives and overall program implementation
- Job requires relationship building, Project management skills and team leadership skills required. Computer skills required include Outlook, Microsoft Word, Microsoft Excel, and Microsoft PowerPoint with a working knowledge of Series MMIS System, and Internet Explorer
- Does Supervise others (4-6 Distribution/receiving personnel)
- Currently Licensed Nurse in the State of Florida
5
Skills For Clinical Supply Chain Analyst Resume
- Deep knowledge of global supply chain practices (APICS certification desired)
- Certificates in Certified Project Management and/or APICS (CPIM)
- Expertise in clinical trial supply chain management methodologies
- Flouent in in communciaiton in English and Chinese
- Employment with an innovative and future-oriented organization
- Demonstrated ability to workwith all organizational levels and work effectively in a team environment, demonstrate strong verbal and written communication skills
- Ensure Regulatory “green light” as well as “technical green light” (i.e. QA/ QP release) is in place prior to initial and re-supply shipments to clinical sites
- Bachelors in Operations/Supply Chain Management, Engineering, or related Business field
6
Skills For Business Analyst, Clinical Supply Chain Resume
- Proficient in Operational Excellence, Lean Process development, Six Sigma tools and techniques desirable
- Articulate clinical supply chain management processes and strategies to key stakeholders
- Track shipment (i.e. status) of clinical supplies
- Process manual ship requests for non-IXRS studies
- 3 FTEs are direct reports; title is Clinical Supply Chain Associate or above
- Managing relationships and contracts with specialty couriers and providers of logistics equipment including temperature controlled containers, liquid nitrogen dry shippers, and temperature loggers
7
Skills For Manager, Clinical Supply Chain Resume
- Participating in clinical study team meetings to understand the enrollment projections of ongoing and future studies, prepare a forecast, then consult with manufacturing and supply chain managers to ensure adequate inventory. Provide regular updates to management on inventory levels
- Schedule, maintain, and assign manufacturing slots as appropriate to support patient enrollment
- Maintain accurate clinical site database and contact list. Proactively reach out to confirm collections and receipt of material to allow for any necessary adjustments to the production schedule
- Strong computer, organizational, and management skills
- Working knowledge of cGMPs and familiar with US and EU regulations
- Utilize analytical models and generate product demand, supply, and availability analysis during trial planning and/or enrollment
- Assists in training and on-boarding of new employees
- Work to improve final product and shipping package configuration to preserve product integrity
8
Skills For Business Analyst Clinical Supply Chain Resume
- Consult with clinical and regulatory teams to design, translate, and produce compliant labeling
- Assist with development of IRT systems, write and execute user acceptance testing scripts
- Knowledge of internal quality systems including Oracle, Celdox, eQRMs, and eRexS
- Designs and implements strategic plans to forecast and supply study drug to global clinical trials using sound supply chain techniques
- Executes and documents IRT User Acceptance Testing, if required
- Serves as the global project lead on assigned projects, ensuring internal project resources are focused on delivery and client satisfaction
- Maintain accurate inventory records and traceability from patient collection to infusion
- Maintain the Trial Master File (TMF) with documentation related to drug release and shipment
9
Skills For Associate Clinical Supply Chain Manager Resume
- Provides input into user requirement specifications of Interactive Response Technology (IRT) medication management module as needed
- Oversee device accountability metrics to ensure investigational devices are tracked and disposition is monitored
- Reviews interprets and implements supply forecast plans from internal or external source documents and tools
- Develops and provides the client(s) with reports on actual project spend versus budget
- Forecast, track, and Manage Clinical Trial Material manufacturing and supply chain, including raw materials coordination, manufacturing operations, and packaging and labeling
- Work with the Clinical Operations, Quality Systems and Compliance, and Regulatory Affairs departments for clinical trial material planning, forecasting, budgeting, and delivery
- Coordinate with CMC and Quality Assurance (QA) partners to manage technical and quality issues to facilitate uninterrupted supplies
- Interface with QA and CMC groups to support release of clinical supplies material and ensure regulatory submissions are up to date
10
Skills For Clinical Supply Chain & Value Analysis Region Director Resume
- Ensure uninterrupted supplies throughout the duration of clinical studies
- Maintain/track inventory of available clinical supplies and tracks expiration dates
- Responsibility of scheduling and delivery of clinical trial material (CTM) including label and packaging design, randomization, packaging, labeling, and distribution
- Prioritize, organize and manage multiple projects simultaneously
- Working knowledge of GCP and GMP environments and requirements
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