Clinical Supplies Resume Sample

5.0
1 vote
Beryl Heller
26853 Marjolaine Mission,  Phoenix, AZ
+1 (555) 461 4060

Work Experience


Clinical Supplies Manager
06/2015 - PRESENT
Boston, MA
  • Seeks innovative solutions to complex problems
  • Position has budgetary responsibility up to established DOA
  • Related Pharmaceutical Industry or Contract Provider experience and applicable Clinical Supplies experience
  • Facilitates transfer and reconciliation of returned clinical supply drug from investigational sites using the appropriate CSMD
  • Support outsourcing to external vendors (Contract Manufacturing Organizations (CMOs), Contract Clinical Distributors (CCDs) and Interactive Response Technology (IRT) systems) to ensure that labeling, packaging and shipping of CTM is in compliance with Array SOP and applicable regulations through direct communication with CMO’s
  • Participates in review, development, and revision of department SOP’s
  • Supports the Supply Chain team’s development of global supply and procurement strategies including vendor selection
  • Provide input to (Interactive Response Technology) IRT specification design. Recommend IRT threshold levels and optimizes as required to make efficient use of clinical supplies while avoiding stock outs at study sites
Clinical Supplies Operator
01/2009 - 03/2015
Boston, MA
  • Professional experience in clinical supply management
  • Global logistics understanding related to supply chains, import/export and drug depots, comparator or co-therapy product sourcing and project management
  • Strong communication skills in German and English both written and verbal
  • Interface with Array departments (i.e. Clinical Operations, Regulatory, GMP Quality Assurance) to interpret CTM needs from study protocols, define packaging and labeling configurations, support regulatory filings, create and maintain CTM documentation according to established procedures
  • Partner with external vendors (Contract Manufacturing Organizations (CMOs), Contract Clinical Distributors (CCDs)) to plan and implement protocol specific CTM strategies from project start through package configuration, label design and development, GMP production campaigns, distribution to clinical sites, and study close-out
  • Participate in design and implementation Interactive Response Technology (IRT) systems for CTM management
  • Coordinate CTM shipping and logistics activities including management of shipments of CTM from between storage/distribution sites and to clinical trial sites
Clinical Supplies
12/2003 - 09/2008
Detroit, MI
  • Monitor CTM inventory levels and interface with CMC team to ensure trial supplies are supported through appropriate stability programs and/or appropriate expiry dating exists
  • Prepare annual and ad hoc budget projections for assigned projects
  • Knowledgeable and compliant to regulations and requirements for functioning under GMP, GDP, and GCP’s, and Annex 13 EU CT Directive
  • Work independently on projects within a team-oriented environment
  • Innovative thinker with ability to solve complex problems
  • Design and execute packaging and labeling campaigns
  • Requests documentation required to label and package clinical trial material and supplies
  • Receives orders from clinical sites and obtains proper approval, prepares shipment and ships material as required

Education


Everest University - Clearwater Campus
1999 - 2003
Science's Degree in Healthcare

Professional Skills


  • Excellent communication, interpersonal, and follow-through skills with strong attention to detail
  • Strong leadership, project management and interpersonal skills with an ability to effectively work within a multidisciplinary team and manage multiple vendors
  • Strong scientific and technical knowledge skills: in product manufacturing, sterile garbing, warehousing / logistics and inventory management
  • Well-organized, detail-oriented with strong written and verbal communication skills
  • Pharmaceutical, scientific or product development experience with experience in application of project management and planning principles
  • Successfully demonstrated several years (mini-mum of 3 years) of directly related experience as scientist or 3-5 years (for BS) or 1-3 years (for MS)
  • Demonstrate good aseptic technique and understanding of sterile garbing require-ments

How to write Clinical Supplies Resume

Clinical Supplies role is responsible for software, english, procurement, database, logistics, inventory, printing, purchasing, shipping, manufacturing.
To write great resume for clinical supplies job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Clinical Supplies Resume

The section contact information is important in your clinical supplies 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
  • Email
  • Telephone number

Work Experience in Your Clinical Supplies Resume

The section work experience is an essential part of your clinical supplies 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 supplies 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 supplies position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions. Representative Clinical Supplies resume experience can include:

  • Proactively provide ideas to enhance efficiency and/or effectiveness of operations
  • Demonstrate compliant GDP in all GMP records
  • Maintains inventory system for all clinical supplies (drug, equipment, documents, components, etc...) including placing purchasing orders for all materials
  • Interpret packaging specifications to determine drug supply needs for packaging and labeling of clinical supplies
  • Track key supply project milestones ensuring each is met, while working within the cross functional team and keeping all parties informed
  • Complete documentation for all labeling and packaging runs

Education on a Clinical Supplies Resume

Make sure to make education a priority on your clinical supplies resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your clinical supplies 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 Supplies Resume

When listing skills on your clinical supplies 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 supplies skills:

  • Demonstrate good documentation practices according the cGMP requirements for all records.
  • Assist in labeling, packaging and shipment of bulk finished goods to GCS
  • Solid understanding of cGMPs and the clinical research process
  • Experience in a Biotechnology or Pharmaceutical industry supporting Clinical Supplies
  • Operate under the direct supervision/leadership of a Lead Operator and/or Super-visor
  • Experience in clinical trials

List of Typical Experience For a Clinical Supplies Resume

1

Experience For Clinical Supplies Manager Resume

  • Report and present own work at internal meetings
  • Support all, and lead multiple, activities related to assigned projects
  • Is accountable for proactive communication and updates to Clinical Trial Leads on actual recruitment vs. allowed variability from planned recruitment based on supply planning; actively contributes to discussions of scenarios and adaptations to supply planning with Clinical Trial Lead
  • Demonstrates an understanding of Alcon’s systems, cGMP, and Annex 13 regulatory requirements such that clinical supplies documentation produced and distributed remain compliant throughout the chain of custody
  • Adherence to Novartis standards, in particular, quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standards
  • Feedback from other team members/leaders
  • Outcome of risk analyses, process challenge meetings, audits and inspections

List of Typical Skills For a Clinical Supplies Resume

1

Skills For Clinical Supplies Manager Resume

  • Utilize appropriate software and IT systems to effectively manage key project activities
  • Experience working with and managing third-party vendors
  • Contribute to the operational effectiveness of Logistics and Clinical Supply
  • Demonstrating leadership behaviors through positive words and actions
  • Work with the Outsourcing Manager to identify and select the drug packaging vendor
  • Self-starter working with a sense of urgency and acting as a team player
  • Actively contributes to the optimization of the general supply chain planning for development and post marketing approval studies
2

Skills For Clinical Supplies Specialist Resume

  • Managing clinical supplies in a biologics/research environment
  • Acute care hospital setting Required and
  • Acute care hospital setting required
  • Maintain organization and cleanliness of packaging, storage and cooler area for all clinical supplies and materials
  • Perform primary and secondary packaging of clinical drug and supplies
  • Immediately inform Clinical Supplies management and QA of any problems or deviations in packaging procedures
  • Prepare and complete packaging documentation as needed per the schedule
3

Skills For Clinical Supplies Associate Resume

  • Provide planning and forecast for clinical trials related to clinical supplies
  • Collaborate with CMC for drug sourcing needs
  • Coordinate drug supply delivery timelines with Clinical, packaging source area(s), and indirectly with GMP laboratories, QA and Regulatory Affairs
  • Track CTM distribution following up on timelines, shipment conditions/excursions and issues
  • Perform visual and physical inspections of in process and finished products as re-quested
  • Actively participate in teams, projects, networks and/or platforms. Fulfill all related tasks and responsibilities related to own discipline
4

Skills For Clinical Supplies Coordinator Resume

  • Excellent oral and written communication skills, strong interpersonal skills, and ability to work successfully in multidisciplinary teams. Able to work independently or closely with teams
  • B.S. Life Sciences or related field
  • Manage Investigational Product (IP) supply for assigned clinical studies
  • Work collaboratively within Logistics and Clinical Supply (LCS) to provide close coordination of
  • Vendor, Distribution and Systems management activities
  • Knowledge of cGMP and Annex 13 requirements
  • Proficient with equipment and/or instruments
5

Skills For Clinical Supplies Operator Resume

  • Fluent in both English and Mandarin required
  • Accountability for costs, quality, quantity, and timelines for all assigned tasks
  • Oversee design and set-up of Interactive Web Randomization System (IWRS)
  • Maintain close communications with all internal-chain groups to ensure the adequate supply of clinical supplies throughout the duration of a clinical trial
  • Monitor global clinical supply inventory for both IWRS and traditional trials via tracking of specific milestone dates and adjusting drug distribution plan accordingly
  • Coordinate packaging/labeling of CTM with approved cGMP vendors, based on approved demands
  • Coordinate importation documents with CROs and packaging vendor
  • Obtain all finalized documentation of primary and/or secondary packaging and file appropriately
  • Maintain CTM inventory working with vendors to ensure accuracy of inventory systems
6

Skills For Clinical Supplies Associate Manager Resume

  • Track all retest dating internally as well as externally with cGMP vendors
  • Participate in clinical trial project team and vendor meetings
  • Generate IMP manual and Pharmacy manual for clinical sites
  • Support the review of Clinical Trial Materials (CTM) forecasts based on clinical trial study protocols
  • Support development, implementation, and maintenance of IRT systems
  • Adaptability, flexibility, independence and resourcefulness with ability to work with changing timelines and willing to roll-up-sleeves in order to thrive in small company environment
  • Proactively drive the labeling, packaging, release, distribution of clinical supplies at external CMO’s for assigned studies, ensuring the project timeline is met or exceeded. Ensure domestic and global distribution arrangements are in place with external vendors to allow shipment following availability of technical and regulatory releases
7

Skills For Head of Clinical Supplies Technologies Resume

  • In collaboration with relevant partners, create forecasts and packaging design based on study needs to ensure optimized supply plan
  • Partner with key stakeholders (including Quality Assurance and Regulatory Affairs) to ensure supplies are labelled and released for clinical site shipment for global clinical trials
  • Work according to appropriate SOP’s, GLP, GMP, QM, QD, HSE, ISEC and Novartis guidelines
  • Plan, create and execute appropriate change control management according to SOP and QM requirements
  • Responsible for all packaging, distribution and accountability activities in support of the Medical Device portfolio
  • Reviews actual enrollment data and updates the demand forecast and distribution plan based on actual recruitment/demand for ongoing studies
  • Design and/or review label text to meet product requirements and ensure compliance with US and international regulations
  • Represent clinical supplies function at clinical trial team meetings; communicate plan and timelines to internal and external customers and partners
  • Assist with planning and execution of clinical packaging projects, including oversight of CMO scheduling, production of labels, and packaging of clinical trial supplies
8

Skills For Associate Clinical Supplies Coordinator Resume

  • Act as point of contact for third party storage, distribution, and packaging vendors
  • Coordinate and track drug shipments
  • Monitor inventory at depots, sites, and distribution points
  • Perform drug accountability with depots/clinical sites and Sponsor inventories
  • Maintain traceable documentation to support GXP activities
9

Skills For Clinical Supplies Resume

  • Has the potential opportunity to manage clinical projects
  • Plan, perform, monitor and report all operational activities
  • Meet quality, quantity and timelines in all assigned projects, networks and/or plat-forms
  • Actively participates in project teams/meetings/networks and contributes to team goals
  • Proactively contribute requested cost information for projects/networks
  • Evaluate data, draw relevant conclusions and write reports
10

Skills For Clinical Supplies Manager Resume

  • Support quality of clinical supply products through generation of documentation that provides clear evidence of compliance with Novartis QM, QD and global regula-tions
  • Interact/collaborate with other functions in Development to facilitate transfer of knowledge and deliverables with the production of clinical supplies
  • Identify need and opportunity for outsourcing. Provide input to contracts and QA-agreements with 3rd parties and lead outsourced tasks/projects with 3rd parties as appropriate
  • Monitor, and report on Key Performance Indicators (KPI) and performance measures to enable strategic objectives to be met, or corrective action to be taken
  • Plan, perform and contribute to project batch production by proactively considering potential issues associated with equipment, instruments, and processes to allow resolution prior to initiation
  • Create and implement efficient and robust procedures/processes for the manufacture of clinical products
  • Coordinate with team members to ensure all activities required to support batch are successfully completed to maintain scheduled batch activities

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