Cara Mathews-Herr Rt(R) Email and Phone Number
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Experienced Clinical Project Manager and Certified Imaging Specialist with a demonstrated history of working in the pharmaceuticals industry. Skilled in AutoCAD, Microsoft Word, Good Clinical Practice (GCP), and Management. Strong healthcare services professional.
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Senior Global Study ManagerLabcorp Drug Development Apr 2023 - PresentBurlington, North Carolina, Us•Key contact for clients; Liaison between Clients, CRO, and Labcorp·Display strong leadership to ensure successful interactions between Covancestudy team members needed to provide seamless study delivery to the client.·Provide project management oversight; focusing on key client deliverablesthrough enhanced budget, risk, and milestone management.·Facilitate client communications between Client and extended Covance studyteam, including Study Design Lead and Regional Study Coordinator.·Perform review of SOW to ensure quality implementation of client specifics and requirements.·Manage a portfolio of global, high-complexity studies; provides program oversight when necessary.· Act as an ambassador on behalf of the client within Labcorp and across Labcorp business units; exemplifies the concept of Signature Client Servicethrough outstanding, personalized customer service skills·Ensure that all customer expectations are documented and acted upon in compliance with regulatory requirements·Demonstrate through appropriate self-organization the ability to manageconflicting priorities and to make difficult decisions·Act efficiently in an environment with dynamic timelines and priorities·Accountable for the implementation, monitoring and reporting of performance metrics·Actively participate in Labcorp development through continuous process improvement, quality and productivity·Work with appropriate internal and external personnel to understand the culture and pipeline of assigned clients -
Global Study Manager IiLabcorp Drug Development Oct 2020 - Apr 2023Burlington, North Carolina, Us•Global liaison with assigned Diagnostic Client representatives (eg. Diagnostic CRA, Site Monitors, Study Managers) and the internal clients to ensure an outstanding - timely communication.•Accountable for the proper and timely delivery of all the study related aspects and deliverables from win study notice to the closure of the study. •Review the Diagnostic component of study Statement of Work to ensure local feasibility and make appropriate recommendations to the Study Design. •Act as a liaison between the various internal departments involved in the study ( Quality Assurance, Commercial Development, Global Laboratory Services Support, Specimen Storage, Data Management, Client Services, Information Technology). •Develop solutions, resolve issues and approve internal database loading/design plan. •Manage high administrative load, dynamic timelines and priorities, and demonstrate strong interpersonal and communication skills that will build strong internal and external relationships to ensure deliverables are on time and within budget. -
Global Study ManagerLabcorp Drug Development Feb 2018 - Oct 2020Burlington, North Carolina, Us-Key contact for clients; Liaison between Clients And CRO- Ensure successful interactions between study team members needed to provide seamless study delivery to the client- Provide project management oversight; focusing on key client deliverables through budget, risk, and milestone management- Facilitate communications between Client and extended study team, including Study Design Lead and Regional Study Coordinator- Perform review of SOW to ensure quality implementation of client specifics and requirements- Manage a portfolio of global and local studies with varying complexity- Act as an ambassador on behalf of the client - Ensure that all customer expectations are documented and acted upon in compliance with regulatory requirements - Accountable for the implementation, monitoring and reporting of performance metrics - Work with appropriate internal and external personnel to understand the culture and pipeline of assigned clients - Ensure deliverables are on time and within budget - Participate in functional meetings (eg. CLFs) and provide input, keeping processes up to date - Comply with CCLS Global Project Management strategy - Support a culture of continuous improvement, quality and productivity -
Clinical Project ManagerBiomedical Systems Jun 2017 - Feb 2018St. Louis, Mo, Us• Review patient image data for analysis and expert review as required by the FDA• Assist in the design of the imaging and efficacy portions of the clinical protocols as well as the Expert Review protocol• Manage sites/imaging center, providing critical analysis as to the capability of a center to perform required imaging related procedures for a clinical trial. Provide critique analysis on quality of data obtained.• Advise imaging centers on ensuing issues that arise during required procedures, while making evaluations /recommendations on discontinuance of the center’s participation.• Provide analysis as to the practical design of imaging procedures and design of quantifiable efficacy endpoints. Writer and implement the Expert Review procedures, design the randomization procedure to best display image data for obtaining the primary efficacy endpoint data. Work with Data Management to design case report forms for this process.• Attend Investigator meetings and present protocol related image processing. Present the process and procedures for image data acquisition and archival to investigator and study coordinators. Serve as an expert panelist to answer questions on the efficacy design and imaging procedures. -
Assistant Project ManagerBiomedical Systems Oct 2016 - Jun 2017St. Louis, Mo, Us• Assist in the management of all aspects of clinical trials from protocol review to the end of study report. • Comminicate with sponsors, CRO’s, clinical sites, reviewing physicians, and core lab staffs to facilitate the over-all progress of studies and to ensure that project deliverables are met. • Review patient image data for analysis and expert review as required by the FDA• Design the imaging and efficacy portions of the clinical protocols as well as the Expert Review protocol•Manage sites/imaging center, providing critical analysis as to the capability of a center to perform required imaging related procedures for a clinical trial. Provide critique analysis on quality of data obtained.• Advise imaging centers on ensuing issues that arise during required procedures, while making evaluations /recommendations on discontinuance of the center’s participation.• Track progress of completion of queries submitted to the study centers. Provide support to the study centers with questions regarding query issues• Conduct study center /Sponsor Internet training sessions• Provide technical assistance to independent reviewers during reading sessions• Assist in the development of departmental Standard Operating Procedures. -
Medical Imaging SpecialistBiomedical Systems Sep 2015 - Oct 2016St. Louis, Mo, UsPerform daily QC on clinical trial data (i.e. imaging, EEG and/or pathology data) received from the clinical sites. Issue queries to clinical sites and follow up on those queries until resolved. Import imaging data into study specific and provide support to Imaging Project Managers as needed.Key Responsibilities• Follow guidelines consistent with Good Clinical Practices and internal standard operating procedures.• Provide critical analysis as to the capability of a center to perform required imaging related procedures for a trial.• Provide quality assurance evaluation of imaging and document data for analysis and expert review as required by the FDA.• Initiate the request for the creation of study specific databases to the Director of Imaging Applications or designee. Ensure new or existing personnel have access to respective databases when applicable.• Blinding, editing, digitizing and preparing study data prior to the importation into study specific databases.• Import clinical trial data into study specific databases.• Assist with read set up and support.• Provide technical assistance to the study centers for issues relating to the clinical trial data and provide possible solutions.• Initiate and track queries to the study centers. Provide support to the study centers with questions regarding query issues.• Assist Project Manager in preparation of study specific documents and manuals. -
Radiologic TechnologistAccuhealth Urgent Care Jun 2015 - Sep 2015
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Radiologic TechnologistCentral Orthopedics And Sports Medicine Nov 2014 - Sep 2015
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Administrative AssistantNewspace Jan 2007 - Mar 2010
Cara Mathews-Herr Rt(R) Skills
Cara Mathews-Herr Rt(R) Education Details
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Saint Louis Community College-Forest ParkComputed Tomography -
Saint Louis Community College-Forest ParkRadiologic Technology/Science - Radiographer -
Maroa/Forsyth
Frequently Asked Questions about Cara Mathews-Herr Rt(R)
What company does Cara Mathews-Herr Rt(R) work for?
Cara Mathews-Herr Rt(R) works for Labcorp Drug Development
What is Cara Mathews-Herr Rt(R)'s role at the current company?
Cara Mathews-Herr Rt(R)'s current role is Senior Global Study Manager at Labcorp Drug Development.
What is Cara Mathews-Herr Rt(R)'s email address?
Cara Mathews-Herr Rt(R)'s email address is ca****@****nce.com
What schools did Cara Mathews-Herr Rt(R) attend?
Cara Mathews-Herr Rt(R) attended Saint Louis Community College-Forest Park, Saint Louis Community College-Forest Park, Maroa/forsyth.
What skills is Cara Mathews-Herr Rt(R) known for?
Cara Mathews-Herr Rt(R) has skills like Interior Design, Powerpoint, Social Media, Clinical Trials, Public Speaking, Autocad, Data Management, Photoshop, Event Planning, Clinical Research, Photography, Good Clinical Practice.
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