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Mary is an energetic and passionate leader with twenty five years of experience in the clinical trial research industry. Now a founding partner at Harpula, where she is looking to foster the growth of next-generation clinical trial technology, her clinical research path was built through multi-national CROs. In these roles, she was responsible for execution of operational, technology and regulatory requirements for Phase I-IV trials. As the Chief Operating Officer at Synteract, Mary contributed to the growth and success of the company through process improvement, team development, and customer delivery resulting in double digit revenue and profitability growth and a successful 4X sale to Syneos Health.Mary's passion is working with people to attain lofty goals, and she has loved defining and managing teams from 20 to 500 people to achieve deliverables as well as quality, revenue, and profitability targets. Mary's broad-based skills in identification and implementation of clinical technology solutions have developed by identifying and implementing solutions for CRO and SMO needs in growth environments. Mary has shown proven leadership in organizational change, team development, and process creation as well as defining and developing global teams to meet the demands of today’s clinical research environment.
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Chief Operating Officer & Founding PartnerHarpula Oct 2022 - PresentHarpula seeks to acquire companies and assets to build a company that excels in today’s Drug Development landscape through technology and services to support innovation, enable personalized medicine, and increase patient centricity. -
Executive Vice President, Global Operations For Synteract, A Syneos Health CompanySynteract Jan 2021 - Mar 2022Morrisville, North Carolina, UsPartnered with Syneos Health leadership to navigate the integration of Synteract into Syneos Health post-acquisition. Focused on the quality delivery of Synteract’s global operational services to our small and emerging biopharm customer base in clinical operations, feasibility, project management, regulatory operations and consulting, biometrics and safety management. -
Chief Operating OfficerSynteract Aug 2019 - Dec 2020Morrisville, North Carolina, UsDrove Synteract’s global operational services including clinical operations, feasibility, project management, regulatory operations and consulting, biometrics and safety management. Together with the Synteract leadership team set strategic direction and enhanced process and technology resulting in a successful company sale. -
Senior Vice President Biometrics & Drug SafetySynteract Jan 2018 - Aug 2019Morrisville, North Carolina, UsHead of the Global Biometrics and Drug Safety teams including Data Management, Biostatistics & Programming, Medical Writing, Pharmacometrics, and Drug Safety. Partnering with the leadership team to identify and implement clinical technology solutions designed to optimize the delivery of quality clinical trial data and analysis. Involved in vendor qualification and selection, merger and acquisition activity, and overall growth of Synteract. -
Executive Vice President, Global Biometrics & Information TechnologyAccelovance, Inc. Jul 2016 - Dec 2017Head of the Biometrics operational teams leading delivery of data management, clinical programming, and biostatistical services globally. Oversight of the Patient Engagement Solutions team which provided support for patient recruitment and retention and data collection via a call center. Additionally responsible for the global Information Technology infrastructure of the corporation including SaaS vendor management, MSP management, core IT operations team, and alignment of clinical technologies to support CRO and SMO delivery. Responsible for integrating teams, processes, and technical infrastructure as a result of merger and acquisition driving corporate growth.
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Vice President, Data Management & BiostatisticsAccelovance, Inc. Feb 2015 - Jun 2016Lead the team that delivered data management, clinical programming, and biostatistical services to our sponsors. Responsible for the identification and implementation of clinical system technologies. Developed the strategy to select and implement the clinical trial management solution and analytic reporting capabilities for the organization. Focused on the growth and development of our biometrics services to serve and expand our sponsor partnerships.
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Executive Director Of Clinical Informatics DeliveryPra Health Sciences Jul 2011 - Feb 2015Raleigh, North Carolina, UsHead of the Clinical Informatics Delivery business unit where technical project managers were responsible for client relationships and high quality delivery of Phase I-IV drug development services. Clinical Informatics services included data management, clinical programming, biostatistics, medical writing, drug safety, and regulatory publishing. Focused on strategic client relationship management, project management, clinical system vendor management, and overall staff development. Created and developed a globally-dispersed team of leaders skilled in project management and client relationship management. Coordinated implementation of multiple technologies within the clinical trial environment to capture, manage, transform, and display data and information. -
Executive Director, Data ManagementPra Health Sciences Jan 2009 - Jun 2011Raleigh, North Carolina, UsGlobal head of Clinical Data Management operations (approximately 500 staff) at a mid-size CRO; responsible for high quality performance, profitability, and appropriate resourcing to meet delivery needs for all studies in Phases I-IV. Responsible for identification and integration of clinical data management technologies including a variety of electronic data capture (EDC) platforms, integrated IVRS solutions, electronic patient reported outcomes (ePRO), and automated processing tools. Therapeutic experience concentrated in oncology, antimicrobial resistance, anti-epileptics, and genetics. -
Director, Clinical Data ManagementPra Health Sciences Jan 2005 - Jan 2009Raleigh, North Carolina, UsDirected Lead Data Managers (Data Management Project Managers) distributed globally both in offices and regional locations. Ensured staff met or exceeded project objectives through project management skill, strategic data management planning and implementation, financial and milestone tracking, and effective training initiatives. Applied metrics and data analysis to identify and implement data management process, quality, and system improvements. -
Director, Data Management & Analysis ReportingPra Health Sciences Jan 2004 - Jan 2005Raleigh, North Carolina, UsDirected the Charlottesville Clinical Data Management and Analysis Reporting departments (approximately 135 staff) to meet or exceed project objectives with high quality clinical study protocols, data management plans, clinical databases, statistical analysis plans, tables, figures and listings, clinical study reports, regulatory submission documents, and electronic filing of new drug applications. Participated in the strategic selection of electronic data capture (EDC) service partners. Implemented organizational change that included consolidation of nine offices into three and dissolution of the Charlottesville Clinical Data Management team. -
Clinical Data Coordinator To Director, Clinical Data ManagementPra Health Sciences Nov 1999 - Dec 2003Raleigh, North Carolina, UsProgressive positions from core data manager, functional line manager, up to the director of the team. Led a 30% growth to 100 data management professionals in the Charlottesville location. Provided leadership in the delivery of clinical data management services (data entry, data review, database programming, medical coding) to clients, primarily for oncology trials. Deeply involved in the early deployment of electronic data capture (EDC) within PRA as well as multiple sponsors. -
Project Manager/Micro AnalystMrl Pharmaceutical Services Jun 1997 - Sep 1999MRL Pharmaceutical Services is now part of Eurofins Medinet.Managed inter-departmental teams and served as the primary client contact for anti-infective in vitro and clinical trial projects for studies ranging from 10 to 350 sites. Forecasted and provided estimates to complete, performed revenue recognition, monitored billing milestones and invoicing. Conducted data management and data analysis of in vitro antimicrobial resistance trial data and electronic surveillance data using SAS software. Performed all data management activities for data as well as generated analysis plans and subsequent tables and listings, then authored scientific manuscripts, abstracts, and posters.
Mary Hickey Mattes Skills
Mary Hickey Mattes Education Details
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The College Of Saint RoseMinor Chemistry
Frequently Asked Questions about Mary Hickey Mattes
What company does Mary Hickey Mattes work for?
Mary Hickey Mattes works for Harpula
What is Mary Hickey Mattes's role at the current company?
Mary Hickey Mattes's current role is COO & Founding Partner at Harpula.
What is Mary Hickey Mattes's email address?
Mary Hickey Mattes's email address is ma****@****act.com
What is Mary Hickey Mattes's direct phone number?
Mary Hickey Mattes's direct phone number is +124023*****
What schools did Mary Hickey Mattes attend?
Mary Hickey Mattes attended The College Of Saint Rose.
What skills is Mary Hickey Mattes known for?
Mary Hickey Mattes has skills like Clinical Data Management, Edc, Cro, Clinical Trials, Data Management, Pharmaceutical Industry, Oncology, Cro Management, Clinical Development, Clinical Research, Gcp, Ctms.
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