Leading a great team of clinical trial rock stars focusing on improving the lives of women through diagnostics.

Supervise and manage more than $20+ million in contracts. All directed studies accumulate 40 - 70% over the budgeted margin, with one trial exceeding the first 8 milestones. Proactively identify potential issues and risks across the program while successfully implementing solutions. Spearhead project processes for regional and global cross-functional clinical trials. Provide oversight to vendors, staff, and 2 project management mentees. Design and configure all aspects of clinical trials, within the budget constraints and designated timelines. Create detailed risk mitigation strategies, associated issue resolution, and contributions to the cross-functional management plans.Key Contributions*Study Management Plans – Curates top tier documents that include the Clinical Monitoring Plan, Communication Plan, Data Cleaning Plan, Case Report Form (CRF) completion guidelines for Oracle Data Capture, and study training materials for Julius Clinical kick off meeting and investigator meetings.*Vaccine Study Assignments - Completed 6 randomized, placebo-controlled, observer blinded trials to evaluate a variety of vaccines, such as a Phase 3 pneumococcal vaccine trial which consisted of 21 sites and 1710 subjects in the United States and a Group B Streptococcus in pregnant women, consisting of 3 sites and 586 subjects in South Africa.*Subject Matter Expert (SME) on protocol deviations in the Pfizer space for the organization.

Advanced the results of one of the largest, clinical trials in the United States through superior input and insight. Improved overall accountability for site selections, while also acting as a functional leader for clinical operations. Oversaw 18 CRAs and 52 sites across the United States and Canada. Led cross-functional meetings to represent the team and provide valuable input. Rendered astute service while managing time demands and unexpected incidents. Guaranteed compliance with ICON SOPs, study contracts, budgets, and all quality standards and regulations.

Determined the scope of work (SOW) for all clinical operations through needs analyses and collaborating with the clinical operations team. Spearheaded implementation projects involving numerous sample testing source documents, QC device logs, and CRFs. Developed training materials and tests for the Quidel (Triage) device platform to heighten learning for 20 clinical team members based on previous operational concerns, resulting in 100% attendance. Managed adjudication team of key opinion leaders. Joined the collaborative effort on proof of concept for the effect of exercise on insulin resistance clinical trial. Influential decision maker regarding developing trial plans and executing operational changes across multiple studies.Key Contributions*“Effect of Exercise of Insulin Resistance” - Supported research for the impact of exercise and insulin resistance for 1 site in the United States and 2 sites in Europe. Study start up and close out for pharmacokinetics of insulin lispro to further research novel insulin on board calculations in the United States.*“Evaluation of Whole Blood versus Plasma Results for the Triage of Cardiorenal Panel” - Compiled and evaluated information for the study of whole blood versus plasma results for Triage Cardiorenal Panel for 4 sites in the United States; including all phases of the study start up and study close-out.

Organized and traced enrollment in a variety of studies, while also tracking timelines. Alleviated risk to study timelines by managing and intervening in recruitment. Supervised site compliance and offered guidance for protocol conduct. Ensured high-quality performance by training and overseeing contract and in-house CRAs vendor and SMO. Using Inform, responsible for clinical data analysis (prevalence, PDs, endpoints, patient level data across the study), querying sites and managing/closing CRA and site queries. With CMO, Dir. of Clin Ops, and a Data Manager was intimately involved in all aspects of study planning, management and analysis and interpretation of data. Created CRFs, ISF documents, regulatory submission and data collection tools.Key Contributions*Infectious Disease – Managed a study for a non-invasive test utilized to detect intra-amniotic infections and predict preterm birth in women presenting with preterm labor and intact amniotic membranes. Headed study start-up, maintenance, and enrollment for 26 sites within the United States.

Tracked timelines, study-wide enrollment, management and intervention of recruitment to mitigate risk to study timelines. Delivered guidance for conduct of protocol, while monitoring site compliance to ensure all tasks are completed correctly and effectively. Mentored and managed CRAs to enhance performance and functioning.Key Contributions*Muscular Dystrophy / Neurologic – Phase 1/2 study that examined restoring dystrophin expressions inDuchenne Muscular Dystrophy. Two sites in UK.*Cardiology / Device – Clinical study that assessed the safety and effectiveness of ex-vivo Vein Graft Exposure to AVI-5126 in coronary artery by-pass grafting to reduce clinical graft failure for 18 sites globally; 2216 subjects.

Phase I/IIFacilitate/coordinate all lab/clinical needs for two physician led oncology protocols with the hospital staff and patientsMaintain all documents relating to the protocols (regulatory, protocol revisions, ICF, CRFs, patient source documents)Coordinate and conduct patient care visits and assured all procedures were conducted in compliance with the clinical protocol

Phase I/IVSupervision of 3 coordinators and 3 P.I.sMaintain an efficient, well organized, financially successful research clinicHost site qualification, initiation, and sponsor visits

Phase I/IVMaintain a high level of knowledge and understanding of assigned protocols (32 total), including all protocol requirements for patient visits, obtaining informed consent, patient visit schedules, test procedures, laboratory information, and drug accountability requirements Complete all study documentation forms, including case report forms and other study specific documents Coordinate and conduct patient care visits and assured all procedures were conducted in compliance with the clinical protocol Interact with sponsor Clinical Research Associate to facilitate the sponsor monitoring and database clean-up process