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..
• Solution driver balancing accountabilities spanning domestic and global site visits, comprehensive database development, management, and closeout, project management, training & development, inventory control and.
• 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.
• 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).

• 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.
• 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.
• 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.