Somerset, New Jersey, United States
Innovative and driven pharmaceutical clinical trial operations and global development professional. Industry experience as a contributor, manager and leader. Adept in clinical trial operations including managing, monitoring, and reporting on clinical trials as well as development operations including data review, writing and submission of global documents. Healthcare professional skilled in supporting innovation including ideation processes and leading pilots. Passionate about clinical trial innovation and bringing solutions to more and more patients faster, more efficiently and as safely as possible. Experienced manager who prizes empowerment, mentoring and teamwork. Therapeutic experience includes: oncology, respiratory, metabolic, vaccine and sexual dysfunction.
Managed CRAs for high performance in line with regulations, SOPs, and company values. Provided coaching/mentoring. Managed onboarding/offboarding.
Facilitated workshops, vendor presentations, ideation sessions and pilots.
Clinical research consulting including monitoring study sites, managing phase I oncology study, data review, file audits and writing/QC study documents.
Managed associates on an Oncology Global Development team supporting operations and documentation. Received an Oncology Global Development Vision Award as part of HA submission team.
Maintained and produced global documents for Oncology Global Development within timelines. Managed studies/tasks coordinating with line functions to complete studies, analyses, review, and reporting.