Lauren Wallace BSN, RN, CCRN
Houston,TX
Summary
Clinical Operations Manager experienced in pediatric cardiac intensive care and advanced mechanical circulatory support technologies. Achieved improved patient management and outcomes through effective clinical trial enrollment, standardized education programs, and cross-functional collaboration. Focused on enhancing operational effectiveness and addressing clinical challenges in high-acuity environments.
Overview
2
2
Certifications
19
19
years of professional experience
Work History
Director, Global Clinical Development
SYN CARDIA SYSTEMS, LLC.
10.2025 - Current
- LEAD CLINICAL OPERATIONS SUPPORTING THE TOTAL ARTIFICIAL HEART PROGRAM AND MULTIDISCIPLINARY CLINICAL TEAMS UTILIZING ADVANCED MECHANICAL CIRCULATORY SUPPORT TECHNOLOGY.
- SUPPORT CLINICAL TRIAL ENROLLMENT AND POST-MARKET SURVEILLANCE ACTIVITIES INVOLVING THE 30CC TOTAL ARTIFICIAL HEART.
- Coordinated clinical activities, case coverage, remote patient management, and operational support across geographically distributed clinical network to enhance patient care delivery.
- PROVIDE CLINICAL LEADERSHIP AND SUBJECT-MATTER EXPERTISE TO CARDIAC SURGEONS, PHYSICIANS, VAD COORDINATORS, PERFUSIONISTS, NURSES, AND HOSPITAL LEADERSHIP MANAGING COMPLEX TOTAL ARTIFICIAL HEART PATIENTS.
- LEAD AND DEVELOP CLINICAL SPECIALIST RESOURCES WHILE ESTABLISHING CONSISTENT WORKFLOWS, CLINICAL SUPPORT PROCESSES, AND STANDARDS OF PRACTICE.
- MONITOR CLINICAL PERFORMANCE AND OPERATIONAL METRICS TO IDENTIFY OPPORTUNITIES FOR PROCESS IMPROVEMENT AND ENHANCED PROGRAM EFFECTIVENESS.
- COLLABORATE WITH ENGINEERING, QUALITY, REGULATORY, AND OTHER INTERNAL STAKEHOLDERS ON CLINICAL AND PRODUCT-RELATED INITIATIVES.
- PROVIDE HANDS-ON CLINICAL AND PROCEDURAL SUPPORT IN HIGH-ACUITY CARDIOVASCULAR ENVIRONMENTS.
- Developed strategy for implantable cardiac support systems and clinical operations.
- Led cross-functional teams across engineering, quality, and regulatory functions.
- Oversaw compliance with FDA, ISO, and medical device requirements.
- Partnered with hospital leaders on product planning and adoption support.
- Oversaw financial management of budgets for system programs to ensure proper allocation of resources., forecasts, and resource plans for system programs.
- Guided senior staff through policy development and daily priorities.
- Recruited, trained, supervised, evaluated and mentored staff members.
- Directed the organization's daily operations, ensuring compliance with applicable laws and regulations.
- Developed policies and procedures to ensure compliance with corporate standards.
- Collaborated with senior leadership to set long-term objectives for the company.
- Served as a public spokesperson at industry events or conferences.
CLINICAL SPECIALIST, HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE
ABBOTT LABORATORIES
07.2024 - 01.2025
- PROVIDED CLINICAL AND PROCEDURAL SUPPORT FOR HEARTMATE 3 LVAD THERAPY ACROSS HOSPITAL-BASED CARDIOVASCULAR PROGRAMS.
- SUPPORTED CARDIAC REGIONS, PHYSICIANS, VAD COORDINATORS, NURSES, PERFUSIONISTS, AND MULTIDISCIPLINARY TEAMS IN THE IMPLEMENTATION AND MANAGEMENT OF ADVANCED MECHANICAL CIRCULATORY SUPPORT.
- PROVIDED INTRAOPERATIVE SUPPORT DURING CARDIOVASCULAR SURGICAL PROCEDURES, ENSURING APPROPRIATE DEVICE UTILIZATION AND CLINICAL SUPPORT.
- Educating healthcare professionals on device operation and patient management, improving adherence to clinical protocols and effective troubleshooting practices.
- BUILT AND MAINTAINED RELATIONSHIPS WITH CLINICAL TEAMS TO FACILITATE EFFECTIVE ADOPTION AND ONGOING MANAGEMENT OF LVAD TECHNOLOGY.
- Collaborated with internal and hospital stakeholders to identify and address clinical challenges, ensuring high-quality patient care and optimal device utilization.
CLINICAL AFFAIRS SPECIALIST, PEDIATRIC VENTRICULAR ASSIST DEVICE
BERLIN HEART INC.
02.2023 - 03.2024
- PROVIDED CLINICAL AFFAIRS AND HANDS-ON CLINICAL SUPPORT FOR BERLIN HEART PEDIATRIC VENTRICULAR ASSIST DEVICE (PVD) IN PEDIATRIC CARDIOVASCULAR AND ADVANCED CARDIAC DISEASE.
- SUPPORT CLINICAL ACTIVITIES ASSOCIATED WITH THE BERLIN HEART IDE CLINICAL TRIAL, PROVIDING HANDS-ON CLINICAL EXPERTISE WITHIN PEDIATRIC CARDIAC PROGRAMS.
- WORKED WITH PEDIATRIC CARDIAC SURGEONS AND MULTIDISCIPLINARY CLINICAL TEAMS SUPPORTING PATIENT TREATMENT AND REHABILITATION.
- SUPPORTED CLINICAL SITES THROUGH DEVICE IMPLEMENTATION, PATIENT MANAGEMENT, CLINICAL EDUCATION, TROUBLESHOOTING, AND PROCEDURAL SUPPORT.
- DEVELOPED AND MAINTAINED STRATEGIC RELATIONSHIPS WITH PEDIATRIC CARDIAC CENTERS, INVESTIGATORS, AND MULTIDISCIPLINARY CLINICAL STAKEHOLDERS TO ENHANCE COLLABORATION.
- Served as a clinical resource to enhance the use of pediatric VADs and cardiovascular devices.
- COLLABORATED WITH INTERNAL AND EXTERNAL STAKEHOLDERS TO IDENTIFY CLINICAL NEEDS AND ALIGN SUPPORT WITH CLINICAL PROGRAM OBJECTIVES.
SENIOR CLINICAL SPECIALIST, TOTAL ARTIFICIAL HEART
SYN CARDIA SYSTEMS, LLC.
06.2021 - 10.2023
- COLLABORATED ON CLINICAL TRIAL ENROLLMENT AND POST-MARKET SURVEILLANCE FOR 30CC TOTAL ARTIFICIAL HEART, FACILITATING PATIENT SELECTION AND CLINICAL FOLLOW-UP.
- Engaged in clinical trial enrollment and post-market surveillance for 30cc total artificial heart, enhancing patient selection processes.
- EDUCATED AND TRAINED SURGEONS, PHYSICIANS, VAD COORDINATORS, PERFUSSIONISTS, NURSES, AND OTHER HEALTHCARE PROFESSIONALS ON DEVICE OPERATION, PATIENT MANAGEMENT, TROUBLESHOOTING, AND CLINICAL PROTOCOLS.
- DEVELOPED AND MAINTAINED STRONG RELATIONSHIPS WITH IMPLANTING CENTERS AND CLINICAL STAKEHOLDERS TO SUPPORT ADVANCED CARDIOVASCULAR TECHNOLOGY.
- PROVIDED ONGOING CLINICAL CONSULTATION AND TROUBLESHOOTING TO SUPPORT PATIENT SAFETY, DEVICE PERFORMANCE, AND CONTINUITY OF CARE.
- Supported hospitals and multidisciplinary teams implementing and managing total artificial heart therapy.
- Collaborated with internal teams to identify clinical needs, improve workflows, and support ongoing clinical program development.
TRAVEL REGISTERED NURSE PCICU, PICU, NICU
CHILDREN'S HOSPITAL OF ATLANTA
10.2022 - 01.2023
TRAVEL REGISTERED NURSE CVICU
CHILDREN'S MEDICAL CENTER DALLAS
01.2022 - 07.2022
TRAVEL REGISTERED NURSE PCIU, NICU, CDHICU
JOHNS HOPKINS ALL CHILDREN'S HOSPITAL
06.2021 - 12.2021
REGISTERED NURSE, RESOURCE NURSE, ECMO CVICU
CHILDREN'S MEDICAL CENTER DALLAS
11.2017 - 06.2021
TRAVEL REGISTERED NURSE PCIU, NICU
KAPIOLANI MEDICAL CENTER FOR WOMEN AND CHILDREN
04.2017 - 10.2017
TRAVEL REGISTERED NURSE PICU, NICU
TRISTAR CENTENNIAL MEDICAL CENTER
12.2016 - 03.2017
ORGAN PROCUREMENT NURSE
LIFEPOINT SOUTH CAROLINA ORGAN PROCUREMENT ORG
05.2016 - 11.2016
CHARGE NURSE CVICU
VANDERBILT CHILDREN'S HOSPITAL
11.2013 - 05.2016
REGISTERED NURSE PICU, NICU
MEDICAL UNIVERSITY OF SOUTH CAROLINA
08.2010 - 08.2013
REGISTERED NURSE PICU, PCICU, NICU
KOSAIR CHILDREN'S HOSPITAL
05.2009 - 07.2010
REGISTERED NURSE PICU, NICU
UNIVERSITY OF KENTUCKY CHILDREN'S HOSPITAL
05.2007 - 05.2009
Education
Masters - Business Administration
Texas A&M University
College Station, TX 10.2026 - 10.2026
Bachelors of Science - Nursing
Berea College
Skills
- Clinical operations management
- Clinical trial management
- Clinical strategy
- Patient management
- Regulatory oversight
- Cross functional leadership
- Project coordination
- Healthcare administration
Personal Information
Title: Clinical Operations Manager, Pediatric Cardiovascular Device Leader
Certification
Critical Care Registered Nurse (CCRN), Advanced Cardiovascular Life Support (ACLS), Pediatric Advanced Life Support (PALS), Basic Life Support (BLS)
AWARDS / SCHOLARSHIPS
Title: Clinical Operations Manager, Pediatric Cardiovascular Device Leader
Affiliations
American Association of Critical-Care Nurses
Timeline
Masters - Business Administration
Texas A&M University
10.2026 - 10.2026
Director, Global Clinical Development
SYN CARDIA SYSTEMS, LLC.
10.2025 - Current
CLINICAL SPECIALIST, HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE
ABBOTT LABORATORIES
07.2024 - 01.2025
CLINICAL AFFAIRS SPECIALIST, PEDIATRIC VENTRICULAR ASSIST DEVICE
BERLIN HEART INC.
02.2023 - 03.2024
TRAVEL REGISTERED NURSE PCICU, PICU, NICU
CHILDREN'S HOSPITAL OF ATLANTA
10.2022 - 01.2023
TRAVEL REGISTERED NURSE CVICU
CHILDREN'S MEDICAL CENTER DALLAS
01.2022 - 07.2022
SENIOR CLINICAL SPECIALIST, TOTAL ARTIFICIAL HEART
SYN CARDIA SYSTEMS, LLC.
06.2021 - 10.2023
TRAVEL REGISTERED NURSE PCIU, NICU, CDHICU
JOHNS HOPKINS ALL CHILDREN'S HOSPITAL
06.2021 - 12.2021
REGISTERED NURSE, RESOURCE NURSE, ECMO CVICU
CHILDREN'S MEDICAL CENTER DALLAS
11.2017 - 06.2021
TRAVEL REGISTERED NURSE PCIU, NICU
KAPIOLANI MEDICAL CENTER FOR WOMEN AND CHILDREN
04.2017 - 10.2017
TRAVEL REGISTERED NURSE PICU, NICU
TRISTAR CENTENNIAL MEDICAL CENTER
12.2016 - 03.2017
ORGAN PROCUREMENT NURSE
LIFEPOINT SOUTH CAROLINA ORGAN PROCUREMENT ORG
05.2016 - 11.2016
CHARGE NURSE CVICU
VANDERBILT CHILDREN'S HOSPITAL
11.2013 - 05.2016
REGISTERED NURSE PICU, NICU
MEDICAL UNIVERSITY OF SOUTH CAROLINA
08.2010 - 08.2013
REGISTERED NURSE PICU, PCICU, NICU
KOSAIR CHILDREN'S HOSPITAL
05.2009 - 07.2010
REGISTERED NURSE PICU, NICU
UNIVERSITY OF KENTUCKY CHILDREN'S HOSPITAL
05.2007 - 05.2009
Bachelors of Science - Nursing
Berea College