Clinical Supplies Resume Samples

The Guide To Resume Tailoring

Guide the recruiter to the conclusion that you are the best candidate for the clinical supplies job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies

Tailor your resume & cover letter with wording that best fits for each job you apply

Resume Builder

Create a Resume in Minutes with Professional Resume Templates

CHOOSE THE BEST TEMPLATE - Choose from 15 Leading Templates. No need to think about design details.

USE PRE-WRITTEN BULLET POINTS - Select from thousands of pre-written bullet points.

SAVE YOUR DOCUMENTS IN PDF FILES - Instantly download in PDF format or share a custom link.

Create a Resume in Minutes

C Skiles

Christop

Skiles

8696 Conn Freeway

Los Angeles

+1 (555) 124 9100

8696 Conn Freeway

Los Angeles

Phone

p +1 (555) 124 9100

Experience Experience

Houston, TX

Clinical Supplies Coordinator

Houston, TX

Kiehn Inc

Houston, TX

Clinical Supplies Coordinator

Interfaces with vendors regarding quote requests and processing of vendor invoices; supports Clinical Supply managers with vendor metrics evaluation
Maintain reporting for inventory on-hand, consumption, movements, lot and expiry tracking for all locations where CTM is stored
Review temperature logs for CTM distribution and storage and investigates temperature deviations according to SOP
Participates in the testing of automated randomization and drug supply management systems
Working knowledge of inventory management systems and web based applications a plus
Ensure timely provision of clinical trial material (CTM)
Proficiency with Microsoft applications (WORD, EXCEL, PowerPoint, Project)

Houston, TX

Clinical Supplies Manager

Houston, TX

Cole and Sons

Houston, TX

Clinical Supplies Manager

Providing expertise on IRT settings for operational performance
Packaging strategies (initial and resupply)
Providing review on supply strategy settings and projection values and acting as the expert for the study team
Cold Chain Management
Coordinates primary and secondary packaging, labeling, testing, distribution, return drug management activities with contract providers according to approved budget. Ensures that activities are performed in accordance with statements of work, packaging requests, job orders, regulations and established quality and service level agreements. Processes compliant invoices promptly to ensure optimal value to Shire
Cost tracking
40% Coordinates primary and secondary packaging, labeling, testing, distribution, return drug management activities with contract providers according to approved budget. Ensures that activities are performed in accordance with statements of work, packaging requests, job orders, regulations and established quality and service level agreements. Processes compliant invoices promptly to ensure optimal value to Shire

present

Boston, MA

Clinical Supplies Associate Manager

Boston, MA

Gleason, Hintz and Toy

present

Boston, MA

Clinical Supplies Associate Manager

present

Monitors packaging activities and provides input to management for continual improvement
Establishes and monitors project budgetary spend and communicates variances to teams and management
Develop comparator sourcing plan/strategy and manage comparator sourcing for clinical studies
Produces detailed plans and contingencies and executes on compound/drug related supply chain activities
Manages all business documents to high standards and maintains physical and electronic departmental project files
Develops clinical supply forecasts, packaging and labeling plans
Lead development and adoption of new practices and procedures

Education Education

Bachelor’s Degree in Scientific

University of Delaware

Bachelor’s Degree in Scientific

Skills Skills

1+ year of leadership responsibility Detailed cGMP, GCP and ICT knowledge
Utilizes expertise in Clinical Supply Management best practice principles to assist in the development / improvement of existing business processes and revise or develop associated training materials
Expert knowledge of GMP's and GCP's
Ability to motivate and integrate teams and teach/mentor team members
Ability to discipline and reward employees and perform timely, effective performance evaluations
Coordinate with client and Catalent internal functions/groups to forecast, plan and scheduling of packaging campaigns and drive timeline to desired deliverable
Acts as the client advocate to manage the study/project budget in a good shape during the project lifecycle
Ability to act as a liaison with other departments where necessary
6+ years of relevant industry experience with at least 4 years in clinical supply management and demonstrable knowledge of the complete clinical supplies life cycle
Assist in creating a supply plan requiring multiple packaging campaigns as a result of limited drug life (short expiry) or limited available study drug

Create a Resume in Minutes

15 Clinical Supplies resume templates

Read our complete resume writing guides

Clinical Supplies Manager Resume Examples & Samples

20% Works with Clinical Supplies Planning function to interpret clinical trial drug requests and clinical protocols and to develop supply packaging strategies, timelines and budgets. Utilizes the ClinApps Clinical Supplies Management Database (CSMD) for clinical labeling approval, to request packaging/labeling/distribution jobs, to manage inventory, shipments, and drug return activities. Provides input into Interactive Response Technology (IRT) design for randomization, supplying drug to depots and sites, and for return functionality
25% Interfaces with Clinical Supplies Technologies Team to understand Shire IRT standards and CSMD requirements and proactively designs database methodology and/or trouble-shoots potential challenges
Interfaces with appropriate QA/QP personnel to help plan work activities and to facilitate expeditious release of IMP for shipment to sites
Interfaces with Product Development group within Process Development to ensure that trial supplies are appropriately supported and that appropriate stability programs are in-progress, and/or appropriate expiry dating exists
Works closely with Logistics function to pro-actively plan, document, and facilitate global cross-border supply strategies, including requirements associated with controlled substances, compliance to global trade standards, and in-country investigational product regulatory requirements for delivery of product to final destinations
15% Works with Clinical Supply Specialists to manage and troubleshoot shipment requests, drug returns, CSMD, and IRT processes. Works with them to ensure creation and maintenance of Clinical Supply IMP documentation and product specification files (where required) according to established procedures and to manage IMP inventory for projects assigned
40% Coordinates primary and secondary packaging, labeling, testing, distribution, return drug management activities with contract providers according to approved budget. Ensures that activities are performed in accordance with statements of work, packaging requests, job orders, regulations and established quality and service level agreements. Processes compliant invoices promptly to ensure optimal value to Shire
Degree in Pharmacy, other scientific/technical degree, or significant job related experience
5+ years relevant Pharmaceutical Industry and/or Contact Packager experience is preferred

Clinical Supplies Specialist Resume Examples & Samples

100%
Utilizes the Clinical Supplies Management Database suite of software (CSMD) to facilitate the supply and distribution of clinical material to investigators. Interacts with contractors and internal Shire customers to monitor progress and to troubleshoot when required
Interfaces with Clinical Supplies Technologies Team to understand Shire IRT standards and CSMD requirements
Provides input into Interactive Response Technology (IRT) design and development for return functionality if used
Facilitates transfer and reconciliation of returned clinical supply drug from investigational sites using the appropriate CSMD software or Interactive Response Technology (IRT) service. Interacts with contractors and internal Shire customers to monitor progress and to troubleshoot when required
Maintains Clinical Supply IMP project binders and product specification files in an “audit-ready” state ensuring inclusion of essential documentation and archiving of interim working notes. Coordinates pre-audit/inspection review
Utilizes the Clinical Supplies Management Database suite of software (CSMD) to manage Clinical Supply inventory for projects assigned. Compares periodically to vendor inventory to ensure accuracy and that final product reconciliation is accurately completed
Coordinate and host periodic packaging vendor operational meetings in order to show proper project oversight by setting agenda, insuring operational issues are discussed, and issuing minutes

Clinical Supplies Manager Resume Examples & Samples

Works with Clinical Supplies Planning function to interpret clinical trial drug requests and clinical protocols and to develop supply packaging strategies, timelines and budgets. Utilizes the ClinApps Clinical Supplies Management Database (CSMD) for clinical labeling approval, to request packaging/labeling/distribution jobs, to manage inventory, shipments, and drug return activities. Provides input into Interactive Response Technology (IRT) design for randomization, supplying drug to depots and sites, and for return functionality
Interfaces with Clinical Supplies Technologies Team to understand Shire IRT standards and CSMD requirements and proactively designs database methodology and/or trouble-shoots potential challenges
Coordinates primary and secondary packaging, labeling, testing, distribution, return drug management activities with contract providers according to approved budget. Ensures that activities are performed in accordance with statements of work, packaging requests, job orders, regulations and established quality and service level agreements. Processes compliant invoices promptly to ensure optimal value to Shire

Head of Clinical Supplies Technologies Resume Examples & Samples

60% - CSMD Management Leadership
Directs staff providing operational support to CSMD user community
Responsible for overseeing staff responsible for inter-departmental communications through periodic newsletter
Executes business strategy for system life-cycle development as well required reports
System integration with key external vendor systems, including Shire's internal systems (as applicable)
Directs personnel in qualification and testing of new modules, system upgrades, business process changes, and reports
Directs personnel for the CSMD change control process
Directs personnel and activities in the development of effective training materials, websites, and live-training activities
40% - IRT Development Leadership
Directs staff in providing support to Clinical Supplies group for IRT development and operations
Manages external IRT vendors to ensure Shire's requirements are communicated and incorporated into standard working practices
Works with cross-functional team toward implementing IRT best practices across Shire
Assists in URS requirements gathering review and UAT standards development with each vendor
Represents Clinical Supplies group on IRT Operations committee
BA/BS degree with significant personnel supervisory experience
Excellent working knowledge of IRT technologies and the ClinApps system for the CSMD project

Clinical Supplies Associate Manager Resume Examples & Samples

Manages complex programs with a moderate level of oversight. Proactively keeps management informed of supply plans and timing. Escalates issues appropriately based on risk
Produces detailed plans and contingencies and executes on compound/drug related supply chain activities
Develops clinical supply forecasts, packaging and labeling plans
Interprets clinical plans and offers CTM solutions to teams. Serves as a key resource for clinical supply knowledge and expertise
Develop and implement label strategy and process based on trial requirements, working with clinical, QA and RA
Develop comparator sourcing plan/strategy and manage comparator sourcing for clinical studies
Monitors clinical shipments across multiple CTM distribution depots to ensure timely deliveries and resolve any shipping related issues
Coordinates drug returns and disposal activities with depots
Review inventory reports, rebalance depot inventories, investigate and resolve inventory discrepancies
Assess requirements for import license
Establish sequence and lead-time of each individual operation, including Qualified Person release, to meet shipping date
Tracks and manage product expiration dates and expiration label updates activities
Monitors packaging activities and provides input to management for continual improvement
Establishes and monitors project budgetary spend and communicates variances to teams and management
Evaluates CTM vendors and new CTM technology and processes
Participate in the IRT assessment, determining whether an IRT is appropriate for a given trial from clinical supplies perspective
Participate in IRT specifications development and UAT
Manages Clinical Supplies portion of IRT
Remains current with industry practice, new processes, global Astellas business practice, and emerging Regulatory requirements and responsible for raising awareness and educating the project teams on an ongoing basis
Lead development and adoption of new practices and procedures
Ensures CTM compliance with applicable regulations and guidelines. Educate team members as needed
Represents function on special project teams/task forces with proactive collaboration. Identifies issues and proposes recommended solutions to departmental challenges
Manages all business documents to high standards and maintains physical and electronic departmental project files
Assists with other clinical operational needs as needed
Position may have 0-3 exempt direct reports
B.A./B.S with experience in related areas such as clinical logistics, manufacturing, pharmaceutical supply operations, clinical operations, quality, or another area with CTM technical focus
Minimum of 7 years relevant experience or 5 years with an advanced degree
Proven experience in planning and coordinating global manufacturing/ packaging or other process related activities. Uses experience to reduce cycle time and improve efficiency
Solid understanding of cGMP, GCP & ICH guidelines as related to IP labeling, packaging & distribution
Demonstrated ability to apply critical thinking and problem solving to job challenges
Experience in CTM vendor management, IRT systems
Experience in global trials
Familiarity with drug formulation, container closure systems and stability testing
Proficiency in MS Excel/PowerPoint/Word/MS Project
Excellent communication, organizational skills, and proven experience
Self-starter with the ability to work independently
Professional and leadership presence, team orientation, and ability to coach others in process oriented activities

Clinical Supplies Manager Resume Examples & Samples

Providing expertise on IRT settings for operational performance
Providing review on supply strategy settings and projection values and acting as the expert for the study team
Shipment Management
Interpretation of the Clinical Study Protocol and Investigator Brochure
Packaging strategies (initial and resupply)
Product demand/Forecast planning
Cost tracking
Inventory management (sites and depots)
Cold Chain Management
Expiry date management
Un-blinded Patient Supply Management
Interactions with Client and Client 3rd parties)- chairing weekly teleconferences with the clinical trial manager, the Catalent logistics managers with ad hoc involvement of client, Interactive technologies group, and other functions as required
Label design generation and liaison with regulatory groups to ensure compliance

Clinical Supplies Manager Resume Examples & Samples

IXRS; Requirements, User Requirement Specification input and review, User Acceptance testing, management of drug supply (including initial and resupply levels, manual shipment cancellation/generation)
Proven experience in CTMS
Project Management Qualification will be advantageous
Life Sciences degree or equivalent

Clinical Supplies Manager Resume Examples & Samples

1+ year of leadership responsibility Detailed cGMP, GCP and ICT knowledge
Direct experience with the Clinical Supply process, including manufacturing, auditing, labeling and packaging
Expert knowledge of GMP's and GCP's
Ability to discipline and reward employees and perform timely, effective performance evaluations
Effective organizational, planning and negotiation skills
Effective oral and written communications
Ability to act as a liaison with other departments where necessary

Clinical Supplies Manager Resume Examples & Samples

You will be required to provide expertise on IRT settings for operational performance and providing review on supply strategy settings and act as the expert for study team
You will manage Shipping, cost tracking, inventory (sites and depots) in addition to Cold chain management and expiry date management
Your role will also require you to investigate and interpret the Clinical Study Protocol and Investigator Brochure
The role also requires your ability to be able to control the packaging strategies (initial and resupply) product demand, forecast planning and cost tracking and Un-blinded Patient Supply Management
You will also control interactions with Client and Client 3rd parties - chairing weekly teleconferences with the clinical trial manager, the Catalent logistics managers with ad hoc involvement of client, Interactive technologies group, and other functions as required

Associate Clinical Supplies Coordinator Resume Examples & Samples

Assist in process-improvement projects
Assist in authoring the Standard Operating Procedures (SOPs)
Assist in completion of routine technical and operational activities for a compound/indication, or equivalent, through maintenance of internal and external resources, for an assigned group of clinical trials
Work on routine processes, across functions
Work on routine assignments that require a certain degree of independent action on you part
Cooperate and interact with the clinical protocol teams and provide input for packaging and labeling configuration or labeling options
Cooperate and interact with the Biostatistics, Clinicians, Materials Management, Quality Assurance, Formulation, Process Development, and Regulatory Affairs groups and provide input for packaging and labeling configuration or labeling options
Assist in routine work activities on multiple projects related to the labeling and distribution of clinical supplies and ensure that the clinical-supply-study start dates are met
Assist in coordinating the packaging and labeling activities at Gilead and contractor sites, including label artwork design, obtaining approval of label text, approving blinded codes, and writing and approving batch records
Perform PPS, IQS, RCVS, EQMS and EBS (computerized software) transactions and prepare purchase orders for specific software programs
Performs qualification, or characterization, of packaging components, including labels, cartons, bottles, and caps
Cooperate and interact with external vendors on issues such as procurement of raw materials, scheduling, and performing operations, including generating and reviewing documentation
Under guidance, lead one specific component of departmental strategic initiatives
BA/BS degree in Pharmacy or Packaging Engineering, or related scientific field and minimum of 2 years of experience in formulation development, clinical or commercial manufacturing, packaging engineering or clinical packaging (labeling or distribution), or relevant
Able to anticipate routine client obstacles, and difficulties, and act upon this in order to meet goals
Able to anticipate routine obstacles and difficulties that clients might experience and initate actions to prevent them
Able to write clear, concise, and error-free documents
Able to exercise judgment, within well-defined and established procedures and policies, to determine and take appropriate action
Working knowledge of: U.S. Food and Drug Administration (FDA) protocols, current Good Manufacturing Practice (cGMP) standards, and Good Clinical Practices (GCP) standards
Good communication (verbal and written), interpersonal, and computer skills

Clinical Supplies Specialist Resume Examples & Samples

Minimum of 3 years relevant clinical research experience in a pharmaceutical company/CRO, including at least 1 year of clinical and ancillary supplies management responsibility
Working knowledge of ICH, FDA, GMP and other applicable regulations/guidelines; familiarity with clinical supply related documents
Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe
Excellent communication / writing skills
Strong computer skills with an ability to access and leverage technology alternatives
Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies
Self-motivation with the ability to work under pressure to meet deadlines
Detail and process oriented
Positive attitude and approach
Multi-tasking capability

Clinical Supplies Associate Resume Examples & Samples

Ensure timely provision of clinical trial material (CTM) for Array sponsored clinical trials and other clinical trials which utilize CTM provided by Array by performing the following activities. Includes initiation of drug shipments from manufacture site to storage/distribution site and to clinical trial sites
Review temperature logs for shipping drug and investigates temperature deviations according to SOP
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
Maintain reporting for inventory on-hand, consumption, movements, lot and expiry tracking for all locations where client inventory is stored
Coordinate with internal operational departments and participating clinical sites to ensure on time delivery of CTM to distribution sites and to clinical trial sites
Participates in review, development, and revision of department SOP’s
Clinical Supplies specific training and courses helpful
Knowledge of cGMP and GCP requirements for Clinical Trial Materials helpful

Clinical Supplies Manager Resume Examples & Samples

Understand and translate clinical study protocol requirements into demand for drug product within a clinical study
Use simulation tools and supply chain expertise to provide decision in support of the design of optimized, lean supply chains for individual studies or programs
Create initial study drug projections and supply plan for clinical supply needs throughout life of study including multiple drug campaigns and appropriate drug strategies
Assist in re-forecasting clinical supplies as a result of strategy changes occurring during the study (enrollment per country, number of sites per country, addition of new countries, etc.) to determine and anticipate the impact on supply forecasts and supply plans
Assist in creating a supply plan requiring multiple packaging campaigns as a result of limited drug life (short expiry) or limited available study drug
Provide input to 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
Works with IRT in creation of system specifications (URS) associated with supply algorithms
Act as Unblinded Study Drug Manager in testing of IRT system (UAT) and throughout life of the study
Monitor and oversee Warehouse and Depot drug levels within IRT throughout study
Establish reports within IRT (blinded / unblinded) that will be required to monitor/track drug usage and drug forecasting throughout project life
Manage drug supply quantities for distribution to designated Warehouses and Depots throughout study
Assist in the provision of budget estimates in support of quotations for clients
Coordinate with client and packager to forecast, plan and scheduling of packaging campaigns and drive timeline to desired deliverable
May provide support of training of other Project Managers in aspects of clinical supply management
May provide input in development / improvement of existing business processes and contribute to the revision or development of associated training materials
May participate in Business Development activities to grow the business
Bachelor's degree in a science, supply chain or related discipline
6+ years of relevant industry experience with at least 4 years in clinical supply management and demonstrable knowledge of the complete clinical supplies life cycle
Experience in supply tracking requirements and systems
Experience in the use of forecasting tools
Global logistics experience/understanding related to supply chains, import/export and drug depots, comparator or co-therapy product sourcing and project management
Working knowledge of the International Conference on Harmonization (ICH) guidelines, Good Clinical Practice (GCP), the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines and a solid understanding of Good Manufacturing Practices (GMP), the Code of Federal Regulations (CFR),
Working knowledge of global supply labeling requirements
Understand the roles/responsibilities and inter-dependencies for key functions involved in clinical supply
Strong knowledge in IRT technology as it relates to supply chain management
Skilled in client relationship management and ability to influence customer demand
Excellent interpersonal skills and problem solving/decision making skills
Extensive experience of using MS Office programs, with a particular aptitude for MS project and Excel

Clinical Supplies Operator Resume Examples & Samples

Responsible for labeling/kitting, distribution and accountability activities in support of the Medical Device portfolio
Generates secondary packaging and distribution instructions; creates airbills and other shipping documentation
Demonstrates an understanding of Client's systems, cGMP, and Annex 13 regulatory requirements such that clinical supplies documentation produced and distributed remain compliant throughout the chain of custody
Creates, updates, reviews, maintains and archives records and other key documents to provide track and trace evidence for every aspect of the secondary packaging and distribution of investigational product in a cGMP state
Accountability for specific record types will be based on job assignments. If label printing is a part of job assignments, demonstrates knowledge of labeling requirements along with the knowledge of printing clinical labels
Demonstrates good working knowledge of inventory management best practices. This may be inclusive of any of the following, log books and their correct entry, WIP, quarantine, retention samples, reference samples, released goods, returned and discarded goods

Clinical Supplies Manager Resume Examples & Samples

Experience in relevant industry with at least 4 years experience in clinical supply management and demonstrable knowledge of the complete clinical supplies life cycle
Working knowledge of the International Conference on Harmonization (ICH) guidelines, Good Clinical Practice (GCP), the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines and a solid understanding of Good Manufacturing Practices (GMP), the Code of Federal Regulations (CFR)
Experience in supply tracking requirements and systems, forecasting tools and knowledge of global supply labeling requirements

Clinical Supplies Coordinator Resume Examples & Samples

Assists Clinical Supply managers on logistics and completion of tasks to support clinical study protocols such as management of packaging operations, label generation and approvals, distribution plans and returns and reconciliation
Interfaces with vendors regarding quote requests and processing of vendor invoices; supports Clinical Supply managers with vendor metrics evaluation
Supports a variety of logistics issues, duties include but are not limited to supply chain services, inventory control, import-export, shipment of products and third party warehousing
Participates in the testing of automated randomization and drug supply management systems
Acts as a system administrator to provide support for various Clinical Supplies software tools (inventory forecasting, internal metrics analysis, SharePoint website)
Supports departmental efforts in developing and implementing tools to support cross-functional team needs
An Associates or Bachelor’s degree in healthcare or related field
Experience working under cGMP, cGCP and SOPs required
Working knowledge of inventory management systems and web based applications a plus
Proficiency with Microsoft applications (WORD, EXCEL, PowerPoint, Project)

Clinical Supplies Manager Resume Examples & Samples

Ownership of Clinical Supply Chain activities including planning, labeling, packaging and distribution of Investigational Medicinal Product for multiple projects
Acts as primary point of contact with contract manufacturing partners
Forecasts supply needs in conjunction with Clinical and CMC colleagues
Interacts with Finance to develop budgets and manage costs for clinical supply activities
Supports the Supply Chain team’s development of global supply and procurement strategies including vendor selection
Utilizes appropriate software and IT systems to effectively manage key project activities
Displays proven effectiveness in managing customer expectations and influencing others
Forecasting program level and study level needs. Working with CMC team to design packaging and stability needs
Work with cross functional team including Clinical Operations and CMC to develop program wide supply plan
B.S. and 3-6 years of experience working in a Pharmaceutical Environment, 1-2 years of which are in a Clinical Supplies/Supply Chain, Clinical Operations, Quality, or CMC role in a Biotech, Pharmaceutical, or CRO company
M.S. and 2-4 years of experience working in a Pharmaceutical Environment; 1-2 years in Clinical Supplies
Demonstrated excellence in project management and managing, tracking, and measuring project progress
Technical and Communicative skills
Experience in working with CMC Teams
Clinical Supply management experience using contract manufacturing companies strongly preferred
Work experience must include some of the following: drug development, project management, clinical trials management, pharmaceutical manufacturing/packaging
Working knowledge of regulations relating to clinical labeling, packaging and distribution activities (cGMP, GCP)
Knowledge of Interactive Voice/Web response systems for use in clinical studies

Clinical Supplies Manager Resume Examples & Samples

Design and execute clinical packaging and labeling campaigns, translating clinical protocol information into supply plans and delivering investigational product to sites on time/ budget
Develop timelines and budgets for packaging, labeling & distribution projects
Manage supplier relationships and lead project kick-off and weekly team meetings
Support internal/ external regulatory inspections and audits
Mentor and/ or supervise junior staff as needed
Bachelor degree in technical/ scientific discipline with 3+ years of relevant clinical supply chain experience; 5+ years in pharmaceutical industry
Experience managing contract manufacturing organizations
Experience in US and OUS clinical supplies management
Knowledgeable in cGMP and GCP regulations and the clinical research process
Proficiency in the design and use of IRT systems
Intermediate to advanced software skills (Excel, Project, etc.)
Strong problem-solving skills and detail-oriented
Excellent communication, interpersonal, and cross-functional collaboration skills

Clinical Supplies Coordinator Resume Examples & Samples

Ensure timely provision of clinical trial material (CTM)
Manage outsourcing to external vendors (Contract Manufacturing Organizations (CMOs), Contract Clinical Distributors (CCDs) and Interactive Response Technology (IRT) systems) to ensure labeling, packaging and distribution of CTM is completed on time and in compliance with applicable regulations
Coordinate clinical supply activities with internal Array departments (i.e. Clinical Operations, Regulatory, and GMP Quality Assurance)
Maintain reporting for inventory on-hand, consumption, movements, lot and expiry tracking for all locations where CTM is stored
Manage shipments of CTM from between storage/distribution sites and to clinical trial sites
Review temperature logs for CTM distribution and storage and investigates temperature deviations according to SOP
Generate clinical demand forecasts, conduct supply availability analysis, and communicate results to key stakeholders
BA or BS in a Science or Logistics field or equivalent experience in Clinical Supply
Working knowledge of cGMP and GCP requirements for Clinical Trial Materials
Previous experience in the clinical supplies field required
Self-motivated with a proactive approach to work
Strong organizational skills and the ability to multi-task
Intermediate MS skills in: Word, Excel and PowerPoint

Clinical Supplies Manager Resume Examples & Samples

Provide budget estimates in support of quotations for clients
Acts as the client advocate to manage the study/project budget in a good shape during the project lifecycle
Coordinate with client and Catalent internal functions/groups to forecast, plan and scheduling of packaging campaigns and drive timeline to desired deliverable
Support training of other Project Managers in aspects of clinical supply management
Utilizes expertise in Clinical Supply Management best practice principles to assist in the development / improvement of existing business processes and revise or develop associated training materials
Actively participating in client meetings and Business Development activities to grow the business
Fluent in English and Japanese

Download Clinical Supplies Resume Sample as Image file