Betsy Lowry Email & Phone Number

New Providence, Nj

Managed pivotal, pharmacokinetic, post-market and health economic assessment studies, including the harmonized, multiyear US / Japan OPTIMIZE pivotal study randomizing 1,639 subjects in the US, Japan and Europe. Selected, audited, qualified, contracted, monitored and closed out investigative sites, adhering to GCP and study protocols. Contributed to procurement of CE Mark certification (2015, 2016), PMA (2021) and Shonin (2022) approvals of Class III investigational drug-eluting coronary artery stents and completed annual regulatory reporting requirements.• Solution driver balancing accountabilities spanning domestic and global site visits, comprehensive database development, management, and closeout, project management, training & development, inventory control and shipping of devices and team leadership.• Managed parts of $35M+ pivotal study (74 sites, 1,639 subjects) from protocol writing to endpoint reporting, including:o Hired and tracked performance of the contract research organization (CRO), core labs and other clinical vendors.o Provided forecasts from determination of FMV to finalization of sites and study budgets.o Led special project to review operational reports from 73 U.S. sites to ensure data integrity, remedied all issues. o Submitted and received Medicare Category B coverage for Class III device.o Performed MedDRA coding of adverse events.• Designed, developed and executed study protocols and protocol amendments in close collaboration with company’s Chief Medical Officer and study steering committees.• Wrote SOPs and work instructions.• Worked with CEC and DSMB for study oversight (wrote narratives, organized meetings for data adjudication).• Produced annual, interim and final reports for all on-going and completed studies.• Wrote Informed Consent forms and Investigator Brochures.• Managed, organized and participated in Steering Committee meetings.• Researched and selected EDC and CTMS Systems for use with clinical studies;

Delivered comprehensive leadership of 10 concurrent, multistage clinical trials for medical devices for orthopedic and spine maladies concurrently from design validation to IDE studies in constantly changing roles spanning Medicare/Medicaid Coordinator, Clinical Data Assistant, Clinical Data Coordinator, Clinical Research Associate (CRA), Clinical Research Associate/Data Supervisor, Senior Clinical Research Associate/Data Supervisor, and Clinical Project Leader. Oversaw and mentored up to five people. • Piloted domestic and international clinical studies from start-up to closeout, coordinating quality management, deadlines, and audit readiness requirements. • Led and conferred with clinical investigators, investigational sites, and CROs. Defined and reviewed clinical project deliverables, including protocols/amendments, investigator brochures, study and site budgets, informed consent forms, study manuals, operational plans, and other trial-related documents. • Addressed safety concerns and emerging adverse events. Conducted site initiation visits (SIVs) along with regular follow-ups with clinical sites to monitor enrollment and electronic data capture (EDC) submissions. • Documented studies in support of future audits and permit publication at medical symposia and in medical journals. Instituted corrective action plans at individual clinical sites throughout the study. • Helped develop and modify regulated and non-regulated clinical protocols in concert with independent clinical advisors and as a pivotal member of a project development team. Examined protocols for pre-clinical and animal studies, proposing revisions before initiation. • Originated programs that tracked patient outcomes for lower back pain, sports knee, and lower/upper extremity incorporating physician clinical assessment, patient quality of life, and return to work measures for incorporation into multiple clinical publications in support of company products.