My responsibilities have included overseeing all data management activities from start-up to database lock. I have led experienced teams of database programmers and data management professionals, ensuring that the teams were trained in current industry standards and had the resources to meet the clients’ needs within timelines and budgets. I have 25 years of CRO experience and have managed and/or worked on more than 125 clinical trials, including as data management and programming team lead for two Benicar® new drug applications (NDAs), as a team member for the Floxin Otic®, Adagen®, and Oncaspar® NDAs, and for other trials and submissions including indications of dermatology,gout, arthritis, hypertension, hyperlipidemia, diabetes, HIV, women’s health, infection and cancer. Additionally, I also have vast experience in EDC and digital pen data collection, as well as experience in CDISC submissions, Interactive Voice Response systems (IVRS), device trials and global data management. I am trained in GCP, GCDMP and 21 CFR Part 11 compliance. I have been a team member of process improvement, quality assurance, risk management projects, medical coding, as well as having contributed to staff and business development. I am a Certified Clinical Data Manager (CCDM) in the Society for Clinical Data Management (SCDM). As a member of SCDM, I helped create the organization's second version of the industry-standard Good Clinical Data Management Practices (GCDMP). I am a current member of the Drug Information Association (DIA) and have presented at national SCDM meetings, webinars and various other industry events. Specialties: General data management, patient reported outcomes (PROs), team building, sponsor liaison, study start ups, new technology

Consultant @ Consultant in clinical data management services From December 2013 to Present (1 year 11 months) Director, Electronic Clinical Data Systems @ From January 2009 to November 2013 (4 years 11 months) Cranford, NJDirector, Data Management @ From March 2008 to December 2008 (10 months) Senior Project Director @ From June 1987 to March 2008 (20 years 10 months)

AA, Business Administration @ Raritan Valley Community College From 1978 to 1979 Ellen Goldberg is skilled in: Sop, Computer System..., SAS, Medical Devices, Cardiology, ePRO, EDC, Medical Coding, Data Management, CRO, Team Building, Forms Development, Patient Reported..., Digital Pen Data Capture, Project Management, Clinical Development, SAS programming, Biotechnology, Drug Development, Therapeutic Areas, Clinical Monitoring, Oracle Clinical, Software Documentation, CDISC, GxP, Medical Writing, Databases, Process Improvement, CTMS, ICH-GCP, Cross-functional Team..., Quality Assurance, e-PRO, Regulatory Submissions, Biostatistics, Oncology, Neurology, Clinical Operations, Inform, Biopharmaceuticals, MedDRA, Protocol, CRF design, Diabetes, Immunology, Endocrinology, Pharmaceutics, Rheumatology, Data Validation, Infectious Diseases