Megan Kauffeld
Clinical Supply Manager
Levittown,PA
Summary
Experienced pharmaceutical industry professional, detail oriented, results driven, motivated self-starter with team focus. Experience includes clinical supply management, clinical trial site management, project management, customer service, and leadership within the pharmaceutical industry.
Overview
16
16
years of professional experience
Work History
Manager, Clinical Supply
MEI Pharma
10.2022 - 12.2023
- Interpret protocol information to determine packaging and labeling plan for clinical studies
- Forecast total drug supply for domestic and global Phase 1b through Phase 3 oncology clinical trials
- Lead clinical packaging and labeling operations including master English label text development and label design
- Lead vendor contract, budget accrual and invoice approvals
- Review and approve pre-production and post-production documents, component and label design
- Manage two direct reports from packaging and distribution vendor
- Plan Drug Substance (DS) and Drug Product (DP) manufacturing in collaboration with CMC and QA groups
- Create and maintain new vendor relationships in areas such as IRT, CMO and CRO
- Lead procurement activities for comparator and ancillary supplies for clinical trials
- Developed templates for IP-related study documents including protocols, study and pharmacy manuals
- Provide input to study timeline planning to Clinical Operations and Project Management
- Lead CD&OP monthly cycle, providing final executive summary to company board members.
- Increased team productivity by implementing streamlined processes and effective communication strategies.
- Achieved departmental goals by developing and executing strategic plans and performance metrics.
Clinical Supply Project Manager
ICON, formerly PRA Health Sciences
05.2021 - 09.2022
- Management of end-to-end clinical supply chain logistics for high complexity biotech clinical studies in multiple therapeutic areas
- Develop and assist in selection of appropriate supply forecast models for high complexity clinical studies
- Coordinate procurement activities for investigational product, comparator, and other NIMP and ancillary supplies for clinical supply studies
- Support design and set-up of IVRS system for clinical supply studies
- Interpret relevant protocol information to develop packaging/labeling design for blinded and open label clinical studies
- Coordinate the label text, proofing and transition of clinical supply labels for domestic and rest of world clinical studies
- Facilitate activities for import and export of clinical supplies
- Primary point of contact in communication with all stakeholders to ensure adequate quantity and timely delivery of clinical supplies throughout the duration of the clinical trial
- Coordinate and manage clinical supply manufacturing, primary and secondary packaging activities at contracted vendors
- Resolve clinical supply complaints and address supply replacement requests.
- Established effective communication among team members for enhanced collaboration and successful project completion.
- Developed comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results.
Project Manager
Catalent Pharma Solutions
05.2020 - 05.2021
- Lead project execution for domestic and global pharmaceutical client protocols from pre-award stage thru site shipments
- Lead and maintain client relationship with multiple clients in multiple phases of clinical trial packaging
- Manage budget and invoices for multiple client accounts
- Liaison for Senior Leadership both internally and externally
- Manage client inventory on site and at 3rd party depots
- Generate project plan for packaging
- Lead interaction and integration with IRT vendor for inventory management
- Manage clinical demand forecasts as needed
- Trigger re-supply planning to ensure clinical material availability at sites
- Utilize SAP to track and identify trends for product usage
- Participate in periodic business review meetings with client, site, and executive leadership
- Maintain client pipeline and support development of proposals for repeat and new business
- Identify and drive new business opportunities
- Subject Matter Expert for Direct-To-Patient studies.
Senior Project Coordinator
Catalent Pharma Solutions
02.2019 - 05.2020
- Lead project execution for pharmaceutical client protocols from award stage thru shipment of Finished Goods
- Lead average of 30 clinical trial packaging projects for top revenue generating pharmaceutical client
- Manage monthly forecasting for all projects
- Lead client calls
- Primary point of contact for client and internal departments
- Plan and assist with execution of all client timelines utilizing scheduling software
- Liase with Senior Leadership at client and site level
- Plan and assist with execution of all client timelines
- Maintain agendas, meeting minutes, and KPIs for all client projects
- Report metrics up through relevant stakeholders, including site and global leadership
- Contribute to and participate in client QBRs
- Manage inventory and re-order points of all client owned material on site
- Lead and contribute to internal and external process improvement initiatives
- Mentor Project Coordinators.
Project Coordinator
Catalent Pharma Solutions
09.2017 - 02.2019
- Assist Project Manager with project execution from award stage thru shipment of Finished Good
- Lead single and multi-site clinical trial packaging/storage and distribution projects
- Point of contact for internal departments as well as clients
- Coach/Train newly hired Project Coordinators
- Manage inventory reporting, monitor and track client inventory.
Project Support Specialist
Bioclinica
09.2016 - 09.2017
- Assist Project Manager with project administration
- Site Management for sites of 15 oncology clinical trial protocols
- Point of contact for clients, sites, and sponsors of clinical trials
- Enter, maintain, and track data in internal software
- Create and modify company Standard Operating Procedures (SOPs) related to Clinical Site Management team.
Client Account Coordinator
Ashfield Healthcare, LLC
03.2015 - 03.2016
- Point of contact for Director of Pharmacovigilance and senior staff of pharmaceutical clients
- Manage 3 direct reports
- Handle paperwork flow for call floor and quality monitoring departments
- Data enter Product Quality Complaints into client managed system
- Review, revise, and post all paper related requests for client to client managed system within agreed upon timeline
- Maintain compliance with FDA reporting guidelines of Adverse Events and Product Quality Complaints
- Monitor and provide feedback on inbound calls taken by Licensed Healthcare Communicators
- Maintain, create, update all SOPs in support of all projects.
Call Center Administrative Coordinator
Ashfield Healthcare, LLC
01.2014 - 03.2015
- Manage 10 direct reports
- Monitor and track inbound call volume
- Track and maintain service levels in accordance with contractual agreement with client
- Responsible for creating and maintaining staffing schedules for 3 teams averaging 25 nurses working on multiple inbound and outbound pharmaceutical projects
- Create and manage training materials and conduct trainings
- Assist with client audits
- Manage inclement weather and emergency preparations for call center employees.
Healthcare Communicator
Ashfield Healthcare, LLC
02.2008 - 01.2014
- Handle average of 75 inbound calls per day for pharmaceutical company
- Place an average of 160 outbound calls per day to physicians and pharmacists on behalf of pharmaceutical company
- Create training materials utilized by customer service representatives and licensed healthcare communicators
- Train and certifying licensed healthcare communicators
- Complete schedule for team of 25 nurses working on multiple inbound and outbound pharmaceutical projects.
Education
BS Exercise Science -
East Stroudsburg University
Skills
- Policy Implementation
- Operations Management
- Expense Tracking
- Performance Management
- Project Management
- Supply Chain Management
- Contract Management
- Strategic Planning
- Vendor Management
vendor system proficiency
- IRT - Medidata RTSM/RAVE, Endpoint, Calyx, IXRS 3, Flex Advantage
- Inventory Management - JD Edwards, Bridge, Fusion
- eTMF - Veeva Vault, Transperfect, Master Control, Phlex Global
technical competency
- Microsoft Word
- Excel
- Power Point
- Project
- Outlook
References
References available upon request.
Timeline
Manager, Clinical Supply
MEI Pharma
10.2022 - 12.2023
Clinical Supply Project Manager
ICON, formerly PRA Health Sciences
05.2021 - 09.2022
Project Manager
Catalent Pharma Solutions
05.2020 - 05.2021
Senior Project Coordinator
Catalent Pharma Solutions
02.2019 - 05.2020
Project Coordinator
Catalent Pharma Solutions
09.2017 - 02.2019
Project Support Specialist
Bioclinica
09.2016 - 09.2017
Client Account Coordinator
Ashfield Healthcare, LLC
03.2015 - 03.2016
Call Center Administrative Coordinator
Ashfield Healthcare, LLC
01.2014 - 03.2015
Healthcare Communicator
Ashfield Healthcare, LLC
02.2008 - 01.2014
BS Exercise Science -
East Stroudsburg University
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