Caronne Colepalmer-Hayes, PMP
Head of Delivery & Operations- SaMD Factory at ZS | Medullan- Claim this Profile
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Bio
Experience
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ZS | Medullan
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United States
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IT Services and IT Consulting
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1 - 100 Employee
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Head of Delivery & Operations- SaMD Factory
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Jul 2021 - Sep 2022
Boston, Massachusetts, United States Led team that created Software as a Medical Device (SaMD) product and built out our Quality Management System (QMS) to deliver an ISO 13485 certification. Currently managing infrastructure, operations, and vendor activities, to enable Contract manufacturing capabilities per our ISO 13485 certification. Program level oversight including product strategy, product development, GxP, non-commercial release, and post-market activities. Representing and supporting the Biz Dev team as… Show more Led team that created Software as a Medical Device (SaMD) product and built out our Quality Management System (QMS) to deliver an ISO 13485 certification. Currently managing infrastructure, operations, and vendor activities, to enable Contract manufacturing capabilities per our ISO 13485 certification. Program level oversight including product strategy, product development, GxP, non-commercial release, and post-market activities. Representing and supporting the Biz Dev team as an SME; in content creation, approach definition, and vendor presentations on RFP responses.
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Sr. Project Manager PMO
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Jan 2020 - Jul 2021
Somerville, Massachusetts, United States Managing Product Discovery and Research teams in the creation of innovative Digital products in the Pharma and Healthcare space. Coordinating and implementing UXRs and Research activities. Ownership of UAT activities for interim and final release software builds. Led validation activities for the Clinical Trial study site. Managed and mentored junior Project and Product resources with onboarding, training, and product activities on the project team.
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BioDati, Inc
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United States
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Biotechnology Research
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1 - 100 Employee
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Senior Consulting Project Manager
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Jan 2018 - Apr 2021
Greater Boston Area Project management consultant for BioDati. Provide guidance on best practices and strategic advice in managing projects and agile code development. Also, provide tech company operations consulting - marketing, product evaluation, business operations, etc for a SaaS-based business. Recently performed an evaluation and recommendation of agile Github-integrated project management tools that are appropriately sized for current project mgmt needs.
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Sallie Mae
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United States
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Financial Services
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700 & Above Employee
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Project Manager, Digital Strategy and Design
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Jun 2018 - Jan 2020
Newton, MA Working with the Business and Agile teams from concept to code to launch. Responsible for leading and managing projects across Digital Strategy including UX. Utilizing marketing, user and research analytics to generate business insights to create innovative digital solutions.
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Project Manager, Loan Originations
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Mar 2017 - Jun 2018
Newton, MA Coordinated Next Generation loan origination project, a new Personal Loan product, which generated over $457M in originations in year one. Responsible for creation and presentation of roadmaps, project plans, and progress
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Principal Consultant
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Sep 2010 - Jun 2018
Providing short term consultation in Marketing, Website Design, Business Development and Outreach. We have worked with companies in Learning and Development, Healthcare, Training & Education as well as Sales & Marketing.
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Head of Product and Operations
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Jan 2013 - Feb 2017
SaaS-based product company has developed a continuing education credit management service, which allows medical professionals to track credits in order to satisfy compliance regulations. Successfully taking a company from idea to launch by coordinating Product, Customer, and Operational activities. Used Agile methodologies to define product strategy and created a product roadmap to inform and guide the Development and Design teams. Conducting market research and analysis, creating customer… Show more SaaS-based product company has developed a continuing education credit management service, which allows medical professionals to track credits in order to satisfy compliance regulations. Successfully taking a company from idea to launch by coordinating Product, Customer, and Operational activities. Used Agile methodologies to define product strategy and created a product roadmap to inform and guide the Development and Design teams. Conducting market research and analysis, creating customer stories and generating website content. Designing the website look and feel by producing wireframes, themes, and site testing. Organized and managed trade show booth. Show less
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Operations and Product Manager
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Apr 2011 - Jan 2013
Drug Regulatory Documents Service which provides access to research documents for academia, startups and small biotechs. Created the product roadmap to which lead to a successful product launch. Lead the implementation and management of the OCR project. Designed logo and marketing materials, implemented market research and analysis, competitive research and resource coordination. Provided back-office management services including, legal and financial and documentation, coordinating meetings,… Show more Drug Regulatory Documents Service which provides access to research documents for academia, startups and small biotechs. Created the product roadmap to which lead to a successful product launch. Lead the implementation and management of the OCR project. Designed logo and marketing materials, implemented market research and analysis, competitive research and resource coordination. Provided back-office management services including, legal and financial and documentation, coordinating meetings, events, customer and vendor relations. Show less
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Product Manager and Operations
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Jun 2009 - Sep 2011
eLCe provided Library Cataloging Software focusing on Speciality Libraries. Charged with undertaking market research, analysis and developing customer stories, in order to inform product creation. Lead the team which created website look and feel by designing website mockups and creating and generating website content in HTML. Responsible for designing marketing materials to reinforce the company brand. reinforce company brand.
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Business Operations Manager
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Sep 2006 - May 2010
Massachusetts Co-founded a home remodeling services company. Managed the operations, marketing and finances. Developed estimates, and provided customer support. Accomplishments: Managing all the business aspects and growing a remodeling business. From estimates to designing space plans, Material sourcing and ordering to Invoicing and client relations.
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Sign Language Interpreter
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Apr 1994 - Jun 2006
East Coast Nationally certified sign language interpreter, ASL and Transliteration. Interpreted a variety of assignments/areas: conference, medical, graduate school, legal and Broadway. Also interpreted for State Governors, Ambassadors and a United States President.
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Education
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University of Massachusetts Boston
Bachelor of Arts (BA), Public Administration -
Georgia Perimeter College
Sign Language Interpretation and Translation