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eClinical Management Team

Susan Bornstein, MPH
Executive Vice President, eClinical Solutions
Susan Bornstein, MPH, oversees the eClinical Solutions delivery team who provide a wide range of expert services in support of global clinical trials in the bio-pharma industry. eClinical Solutions focuses primarily on end-to-end data management, EDC implementations, technical consulting and training services. Susan has been involved in clinical research since 1988 and has clinical research leadership experience in both industry and academia. Before joining Eliassen Group in 2006 to launch eClinical Solutions, Susan had been Program Director in the Neurology Global Product Development Unit and Worldwide Director of Data Management at Serono, Inc. where she led global EDC implementation. Before that she had served as Worldwide Senior Director of Data Management at MTRA/AAI Pharma and as Data Analyst at the Center for Human Genetics at Boston University. Susan's industry contributions include: Electronic Clinical Forum Steering Committee Member, SCDM Board of Director, and part of team to initiate the SCDM Good Clinical Data Management Practices.

Jeff Rogers
Executive Vice President, Business Development & Strategy
Jeff Rogers provides the strategic leadership in all sales and business development initiatives for eClinical Solutions. Jeff has been managing sales teams and leading operational efforts for services and solutions organizations since 1988. Prior to joining Eliassen Group in 2007, he was Regional President for the national staffing and managed services provider, Yoh Services. At Yoh, Jeff oversaw the sales and operations personnel in more than 20 locations in the Eastern U.S., as well as in Britain.

Mike McBrierty
Executive Vice President, Technology Staffing Division Recruiting
Mike McBrierty oversees Eliassen Group's recruiting and retention programs for consultants, as well as the Direct Hire division. Based on his over 20 years of staffing industry experience, Mike has built a high performance recruiting team at Eliassen focused on building long-term relationships with consultants and candidates. Before joining Eliassen in 1996, Mike spent 11 years with Sullivan & Cogliano where he had been Recruiting Manager, then Vice President of Recruiting and General Manager.

Kristan Gallitano, M.Ed.
Vice President, Data Management Solutions
Beginning her experience in Biotech and CRO in 1991, Kristan has served in both technical and management positions performing Data Management tasks for Phase I – IV trials and patient registries. She has developed SOPs for paper-, fax- and web- based Data Management systems. She has been responsible for training staff on new processes and implementing new processes across roles. Kristan led a interdepartmental Clinical Development Efficiency Team which was responsible for reviewing the clinical trial process from Trial Planning through Trial Reporting, identifying redundancies and implementing change. She has been responsible for the creation and delivery of clinical development training modules and for the selection and oversight of Data Management and Safety vendors.

Josephine Scrofani, CPLP
Vice President, Training and Consulting Solutions
Josephine began her training and education experience in 1994. Her experience includes management of national CRM (Customer Relationship Management) training implementation focusing on approximately 5000 users, assessment of training needs and training functions. She has knowledge of EDC systems and processes and is responsible for the development of user requirements for system or process implementations. Josephine is responsible for the development of training materials to support training initiative including user guides, reference cards, participant guides, workbooks and job aids as well as the design and development of various training solutions (instructor-led training, web-conferencing, asynchronous eLearning tutorials) applying Adult Learning concepts and the ADDIE Instructional Design Model. She also facilitates the technical, soft skills and process workshops customized to meet client needs and objectives. Josephine is an active member of the SCDM Education Committee and has been certified as CPLP (Certified Professional in Learning and Performance) by the American Society for Training and Development.

Anthony Goncalves
Director, Process and Operations
Anthony began his career in Biotech and CROs in 1996. He has both technical and management experience and he was the EDC Implementation Leader for a biotechnology company responsible for formalizing and standardizing EDC process for global implementation. Anthony has developed and delivered EDC training to end users and was the Functional Service Provider (FSP) Manager for a SAS FSP for a pharmaceutical company.

Raj Indupuri
Director, Technical Solutions
Raj began working in IT in 1995 and within the Biotechnology industry in 1997. He has led projects to implement and integrate different components of CDMS/EDC systems. He has evaluated, implemented and maintained EDC and related eCDM technologies. He also worked as an EDC Specialist for a large biotechnology company. He has implemented the operational metrics program and was the Functional Service Provider (FSP) Manager for a SAS FSP for a pharmaceutical company.

Cheryl McCarthy, CQA, CBA
Manager, Quality Assurance
Cheryl began her career in clinical research in 1988 and within the Medical Device, CRO and Biotech industry since 1992. She is an ASQ Certified Quality Auditor and Certified Biomedical Auditor and is experienced with Vendor Assessment Audits. She has developed and implemented Internal Audit programs, Quality Management Systems, Disaster Recovery/Business Continuity plans and Training Compliance programs. She has provided training on 21 CFR Part 11 and GCPs and she is a member of DIA SIACs for GCP/QA and Validation. Cheryl is an active member of the local and national chapters of the Society of Quality Assurance. She has been elected as Vice President of the New England Regional chapter of SQA for 2009 and is co-chair of the Advanced GCP Quality College for the national SQA organization. She is responsible for providing QA support to eClinical Solutions staff and clients.

Bob Arnesen
Director of Sales
Bob Arnesen is responsible for the day-to-day development and management of the eClinical Solutions sales team in support of increasing demands for end-to-end electronic data management and statistical programming services offered by eClinical Solutions. Arnesen joined eClinical Solutions having had significant sales experience in the life sciences sector, most recently as the Director of Business Development at Bridge Laboratories. Previously, Arnesen performed in a variety of sales roles at PHT Corporation, Covance, CRO, Baxter Healthcare, and Johnson and Johnson, Inc.

NEWS & EVENTS

03/20/09
eClinical Solutions Senior Manager Presents at SAS Global Forum 2009

03/12/09
Eliassen Group President Joins NACCB Board of Directors

03/06/09
eClinical Solutions' Senior Managers Offer Two Presentations at the 24th Annual DIA Data Conference and Exhibition