Experience

ORIEL RESEARCH SERVICES

• Ireland
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Owner and Managing Director

  • Jan 2019 - Present

  Ireland I have many years of experience in clinical operations and can provide tailored support to clients bringing investigational products to market. That experience ranges from start up and executive management of a niche CRO to management of an academic site alliance. I am a Senior Consultant for WCG Avoca and lead the Site Quality Leadership Board for the Avoca Quality Consortium, a WCG company.



G&L Scientific

• United States
• Outsourcing and Offshoring Consulting
• 1 - 100 Employee

• VP Clinical Operations

  • Jun 2017 - Dec 2018

  County Dublin, Ireland G & L Scientific provides consulting, staffing and support services to Clinical Research and Regulatory Affairs projects. I provided consulting services and oversaw staff in both the US and EU who supported clients bringing products to market.



Frenova Renal Research

• Senior Director, Integrated Services, Frenova Renal Research, a Fresenius Medical Care company

  • Jun 2010 - May 2017

  Waltham, MA Responsibilities included providing and overseeing select CRO services for study sponsors conducting trials in the renal arena. Launched a niche nephrology CRO in 2010 from concept to the execution of services on multiples Phase 2 and 3 clinical trials. Staffed and nurtured project management, vendor management and monitoring teams. Exceeded enrolment goals and met timelines on two large Phase 3 trials which resulted in repeat business and increased revenue. Promoted from Director to… Show more Responsibilities included providing and overseeing select CRO services for study sponsors conducting trials in the renal arena. Launched a niche nephrology CRO in 2010 from concept to the execution of services on multiples Phase 2 and 3 clinical trials. Staffed and nurtured project management, vendor management and monitoring teams. Exceeded enrolment goals and met timelines on two large Phase 3 trials which resulted in repeat business and increased revenue. Promoted from Director to Senior Director in 2014. Show less



Fresenius Medical Care

• Germany
• Hospitals and Health Care
• 100 - 200 Employee

• Senior Manager of Clinical Studies

  • Jan 2003 - Jun 2010

  Originally hired as National Research Coordinator in 2003, I was promoted over time to different roles with increasing levels of responsibility, project management and oversight of multi-site Phase 1 to Phase IV studies for this large dialysis provider. I initiated audit and compliance activities, education and training and developed SOPs and Working Practice Guidelines. During this time I also completed a Masters in Bioethics.



Biomedical Research Alliance of New York

• VP Clinical Operations

  • Jun 2000 - Apr 2002

  Great Neck, NY Provided clinical oversight of research activities at Alliance facilities (NYU Langone Medical Center, Mount Sinai Medical Center, Montefiore Medical Center, North Shore-Long Island Jewish Health system (now Northwell), St. Vincent's Medical Center).

• Senior Manager, Clinical Affairs, Inpatient Research

  • Sep 1998 - Jun 2000

  Day to day management of multi-therapeutic research activities across academic sites in metropolitan New York for this newly created academic alliance. Protocol Experience: Sepsis, Pancreatitis, ARDS, Pneumonia, Oncology, ESRD, Lyme Disease, RSV, Unstable Angina, CHF, COPD, VRE, Epilepsy, Pain, SLE.