Director, OraNet

• Oct 2020 - Present

Responsible for planning, resourcing, and executing monitoring strategies for multiple clinical trials as well as balance the variables associated with this highly collaborative, matrixed team. As the director of monitoring services, will supervise and mentor a team of monitors, and play a critical role in ensuring that studies conducted by Clinical Operations are appropriately monitored to ensure adherence to all relevant SOPs, thereby ensuring the credibility and rigor of the studies. Ora is the world’s leading independent, full-service ophthalmic clinical research and product development firm with offices in the United States, the United Kingdom and Japan. Over the past 40 years, we helped our clients earn 45 FDA approvals and supported over 1600 domestic and global trials enrolling over 27,000 patients worldwide. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently and successfully bring their new products from concept to market. Ora’s pre-clinical and clinical models, unique methodologies and regulatory strategies have been refined and proven across thousands of projects globally. We bring together the world’s most extensive and experienced network of ophthalmic experts and R&D professionals to maximize the value of new product initiatives. Specialties Allergy, Dry Eye, Retina, Anti-Infective, Anti-Inflammatory, Glaucoma, Dermatology, Medical Devices, Drug Delivery Show less

Director, Monitoring Services

• Mar 2019 - Jul 2020

* Led and mentored a team of 58 monitors to ensure that studies were monitored in adherence to SOPsand all regulatory agency requirements and guidelines· Planned, resourced, and executed monitoring strategies for multiple clinical trials with a highlycollaborative and matrixed team· Managed all aspects of multi-million dollar global clinical trials using Veeva Vault electronic TrialMaster File (eTMF), Clinical Trial Management System (CTMS), Study Startup (SSU), and Electronic DataCapture (EDC)· Collaborated with multidisciplinary teams and key stakeholders to ensure high-quality standards forquality, integrity, and ethics Show less

Senior Manager Monitoring Services

• Feb 2016 - Mar 2019

The Senior Manager, Monitoring Services, serves as a knowledge resource for the CRAs and helps monitoring team members develop their skills. This position may be called upon to interact independently with sponsors and to assist in wider Company tasks as needed. The Senior Manager, Monitoring Services, also works collaboratively with the Director, Monitoring Services, in assessing the qualifications of monitors. This position requires collaboration with cross-functional teams and independence in supporting clinical trial activities. Show less

Manager, CRA Management Group

• Jul 2013 - Feb 2016

Clinical Research Manager , US/East

• Oct 2010 - Jun 2013

Sr. Regional Area Manager

• Nov 2008 - Sep 2010

Liased with Data Management to assist in design of EDC system. Liaised with Urology as primary field contact prior to and during developmental and final phase of OAB trials, neurogenic & idiopathic. Manage upwards of 14 CRAs; mentored, developed, coached. Liased with Data Management to assist in design of EDC system. Liaised with Urology as primary field contact prior to and during developmental and final phase of OAB trials, neurogenic & idiopathic. Manage upwards of 14 CRAs; mentored, developed, coached.

Regional Area Manager

• 1994 - Nov 2008

Clinical Project Leader

• 1993 - 1994

Clinical Research Associate

• 1990 - 1993