Experience

Tepha, Inc.

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Senior Manager, Clinical Operations

  • Nov 2019 - Present



Philips

• Netherlands
• Hospitals and Health Care
• 700 & Above Employee

• Senior Manager, Clinical Affairs

  • Jan 2018 - Nov 2019

  Connected Sensing Venture



Haemonetics

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Senior Clinical Trials Manager

  • Jun 2017 - Jan 2018



Abiomed

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Senior Clinical Program Manager

  • Mar 2016 - May 2017

  Senior Clinical Program Manager for the Global cVAD Registry, the largest (scope and investment) clinical trial initiative at the company consisting of up to 10,000 subjects at 100 sites globallyLead project team consisting of three (3) internal CRAs, one (1) project coordinator, one (1) database administrator, and oversee large CRO that is responsible for site management, monitoring, and database development



Mitralign

• United States
• Medical Equipment Manufacturing

• Director of Medical Affairs Operations

  • Oct 2015 - Mar 2016

  Multiple cross-functional responsibilities including physician education and training, health economics and reimbursement, scientific communications, and market sizing and segmentation



Medtronic

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Clinical Program Manager

  • Jan 2014 - Oct 2015

  Responsible for developing and establishing the first clinical research department for the Interventional Lung Solutions businessWork closely with cross-functional leaders including sales, marketing, R&D, regulatory, scientific communications, pre-clinical, health economics policy & reimbursement, quality, operations, and executive leadership to develop a portfolio of clinical trials to meet the needs of ILS business.Member of the ILS Leadership TeamLead multiple work streams to drive the ILS objectives both domestically and internationallyHired a clinical research team consisting of one (1) project manager, three (3) clinical research associates, and one (1) coordinator to support program growthEstablished trial portfolio of five (5) post-market clinical trials, including a global study consisting of 75 sites and 2,500 subjectsDeveloped and received budget approval for clinical trial department that covers needs of the business for at least the next 5 yearsClinical Affairs representative for business development and licensing team, including participating in diligence activities for potential acquisitions

• Clinical Research Manager

  • Oct 2004 - Jan 2014

  9 years of experience supporting multiple clinical programs in four different business units as described below:Clinical Research Manager (Structural Heart)• Global manager for the CoreValve (transcatheter aortic valve) SURTAVI IDE clinical trial, including oversight of global activities in Europe, Canada, and United States at up to 115 centers with approximately 2,500 subjects (adaptive design) Principal Clinical Research Specialist (Structural Heart)• Assisted with original protocol development and site selection for CoreValve Pivotal IDE trial• Managed all international CoreValve clinical trial activitiesClinical Monitoring Supervisor (Neuromodulation)• Supervised four (4) clinical research monitors (3 field based and 1 internal)• Supervised seven (7) contract monitors• Manage and execute contracts for contract monitors, including negotiating rates, making payments, and identifying monitors as needed for different studies• Supervise all aspects of monitoring activities for assigned trialsSenior Clinical Research Monitor (Neuromodulation)• Conduct monitoring visits in accordance to Medtronic SOPs and applicable regulations for assigned clinical sites• Lead monitor for assigned studiesClinical Research Specialist (Spinal and Biologics)• Responsible for assisting in developing, planning and implementing the overall direction of clinical research projects in accordance with good scientific principles and pertinent government regulations.• Performed daily study management, including communication with clinical site personnel, case report form review, adverse event review, protocol deviation review, and data discrepancy resolution



Accredo Therapeutics

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Patient Representative

  • Dec 2003 - Oct 2004



Accredo Nova Factor Inc

• United States
• Hospitals and Health Care

• Patient Representative

  • Dec 2003 - Oct 2004



University of Tennessee Health Science Center

• Higher Education
• 700 & Above Employee

• Research Assistant

  • Jul 2002 - Dec 2003