About Integrium » Our Team
As experts with a reputation for excellence, Integrium has been able to attract and retain the best and the brightest in the clinical research and development field. Together with our founders, they bring valuable insight to every project, helping clients successfully navigate the complexities of each unique clinical trial.
Executive Team
David H. G. Smith, MD
Founding Partner, Chief Medical Officer
Eileen McAuley, RN, MPA
Chief Operating Officer
Carmen Margaritescu, MD
Medical Director
Pierre Devesly
Executive Director, Clinical Operations
Richard Caroddo, MPA
Senior Director, Business Development
Jessica Coutu
Senior Director, Contract Administration
Ewa Olesiak Deptuch
Senior Director, Finance
Mark McBride, PhD
Senior Director, Biostatistics & Statistical Programming
Adam Steadman
General Manager - Cardiovascular Core Laboratory
Ellen Goldberg
Director, Data Management
Regina Ottaviano
Director, Human Resources
Founding Partner, Chief Medical Officer
David H. G. Smith, MD is one of the founding partners of Integrium and serves as the Chief Medical Officer. In this role, he oversees the Medical Safety department, which provides pharmacovigilance and medical monitoring services. He also works closely with clients on program planning, protocol development and other key clinical matters. Dr. Smith brings substantial experience in clinical research and management to the operational capabilities of Integrium. His leadership has provided the visionary growth and ethical service bias essential in contract services outsourcing.
"Our existence and continued growth has always been in response to client need," according to Dr. Smith. "From the very beginning, our clients, both in the clinical development and marketing sectors of industry, came to us first for advice, and then for focused and efficient effort in the execution of well designed study programs. I am proud of the way Integrium has refined the critical relationship of scientific quality, regulatory muster and marketing relevance —understanding that all are essential to product advancement."
Dr. Smith completed his training in internal medicine and cardiovascular disease at the Veterans Affairs Medical Center, Long Beach, California and at the University of California, Irvine.
Dr. Smith has participated actively in research in the fields of hypertension, hyperlipidemia, diabetes, ischemic heart disorders and exercise stress testing. He has special interests in the study of the renin-angiotensin system, disorders of arterial compliance and endothelial dysfunction, 24-hour ambulatory blood pressure monitoring and the general pharmacotherapy of cardiovascular disorders. In addition to acting as Chief Medical Officer on a number of large international, multicenter clinical trials, he has authored numerous journal articles, abstracts, and book chapters and has formally presented at many scientific meetings. Dr. Smith is a member of several specialty organizations and has been designated as a Specialist in Clinical Hypertension.
Along with his leadership role, Dr. Smith has served many clients in the area of scientific and regulatory consultation and has further assisted sponsors with representation and participation in meetings held with the US Food and Drug Administration, as well as international regulatory authorities.
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Chief Operating Officer
As Chief Operating Officer, Eileen is responsible for driving and managing all aspects of operations. She provides leadership to the organization to ensure corporate objectives are achieved while client deliverables are satisfied. In her role, she is responsible for Project Management, Monitoring Services, Contract Administration, Data Management, Biostatistics & Statistical Programming, Human Resources, Information Technology and Quality Systems Department..
Eileen has worked for more than 20 years in the clinical research arena. Her experience ranges from Clinical Research Associate, Director of Project Management, Senior Director of Clinical Operations and Vice President of Clinical Operations. She has a proven track record for satisfying clients, managing individuals and delivering complex projects on time and within budget..
Eileen received her BS Degree from Montclair State College in New Jersey and began her career as a registered nurse working in critical care. She has a Masters Degree in Public Administration from Seton Hall University, with a focus on Health Policy and Management..
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Medical Director
Dr. Margaritescu serves as the Medical Director of the Medical Affairs department. In this role, she oversees a team of research professionals to provide pharmacovigilance, coding, IND reporting, laboratory surveillance and medical monitoring services, while working closely with clients and the Integrium project team colleagues to meet stringent reporting timelines. Dr. Margaritescu provides over 25 years of clinical research and practice experience and nearly seven years of experience with Integrium.
Dr. Margaritescu completed her training at the University of Medicine and Pharmacy, in Bucharest, Romania. She held the positions of General Practitioner, Senior Specialist in Neurology, and Associate Director in Romania and worked in Clinical Research in the Department of Neurology at the University of Southern California
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Executive Director, Clinical Operations
Pierre Devesly, serving in the position of Executive Director, Clinical Operations, has over 21 years of academic and pharmaceutical industry experience with responsibilities spanning basic research (Oncology and Cardiovascular), quality assurance, clinical monitoring, project management, service provider and international global program direction. Before joining Integrium, Pierre served in senior executive positions in project management and clinical development with Kendle, Quintiles, Eisai, Forest Laboratories and Organon. He has submitted extensive NDAs and INDs in CNS, cardiovascular, GI and IV anesthetic therapeutic areas and has led many partnerships with midsized and large pharmaceutical companies. In his current position, Pierre is responsible for developing Integrium Clinical Excellence (ICE) methodology and managing five departments (Field Operations, Office of Clinical Excellence, Project Management, Data Management, Biostatistics and Medical Writing) to profitability.
As Executive Director, Pierre is accountable for the successful execution of all projects and manages the development of standardized strategies for project execution, pricing and bid defense. He is also responsible for building and maintaining an organization that meets the global needs of Integrium and its sponsors and for assuring that each of his responsible functional areas delivers against the budget, timeline, and quality expected from every sponsor, for every trial. Pierre has a Bachelor of Science degree.
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Senior Director, Business Development
In this role, Richard leads the activities of Integrium, establishing and expanding service relationships with biopharmaceutical clients, as well as directing the business development team in this process. Richard has been with the company since 2002, and he was previously the Director of the business development group.
Richard has more than 15 years of experience in the pharmaceutical and healthcare industries. This experience includes significant business development and contracting activity with biopharmaceutical companies and healthcare providers. He has in-depth knowledge of the details and trends in the clinical development field and the broader business environment in which biopharmaceutical companies operate. He also has a keen interest in how companies adjust to rapidly changing conditions. Richard is an active speaker on clinical development topics at industry conferences and has published a number of articles in the area.
He received a Master of Public Administration degree from Columbia University and a Bachelor of Science degree from the State University of New York at Albany.
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Senior Director, Contract Administration
Jessica Coutu is responsible for the preparation, review and negotiation of contracts with sponsors, investigative sites, consultants and vendors. She is also responsible for the preparation of responses to sponsor requests for proposals and the financial account management of all awarded studies.
Jessica has more than 20 years of experience with proposal preparation and review, contract negotiation, budget development, monitoring and management. Prior to joining Integrium, Jessica was the Director of Contracts and Proposals for two other leading CROs. Before that experience, she was the Associate Director of Grants and Contracts for the Saint Barnabas Health Care System and previous to that was also a position as the Director of Research Development for the Children’s Hospital of New Jersey at Newark Beth Israel Medical Center. In these positions, she managed all clinical trial and basic research activities and was a member of the Institutional Review Board. She has extensive clinical and basic research experience from both private industry and academic institutions, and has additionally presented and published her research. Jessica earned her B.A. in Biology from the University of Rhode Island at Kingston.
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Senior Director, Finance
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Senior Director, Biostatistics & Statistical Programming
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General Manager - Cardiovascular Core Laboratory
Adam has full management responsibility for the Integrium Cardiovascular Core Laboratory located in Tustin, CA. Additionally, Adam is responsible for the marketing of Integriums services, and has particular responsibility for development of the Device & Diagnostics division.
Before joining Integrium, Adam served as General Manager, VP Sales & Marketing, CFO and CEO of several organizations. He has qualified as a Chartered Accountant, and holds a Bachelor of Accounting Science degree and a post-graduate Bachelor of Accounting Science degree (with Honors) from the University of South Africa in Pretoria.
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Director of Data Management
Ellen Goldberg, as Director of Data Management, is responsible for overseeing all data management activities from start-up to database lock at Integrium. Ellen leads an experienced team of database programmers and data management professionals, ensuring that the staff is trained in current industry standards and has the resources to meet the clients’ needs within timelines and budgets.
Ms. Goldberg has more than 20 years of CRO experience and has managed and/or worked on more than 100 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 hypertension, hyperlipidemia, diabetes, HIV, women’s health, infection and cancer. Additionally, Ellen also has vast experience in eDC data collection, as well as experience in CDISC submissions, Interactive Voice Response systems (IVRS), device trials and global data management. She is trained in GCP, GCDMP and 21 CFR Part 11 compliance.
Ellen has been a team member of process improvement, quality assurance, risk management projects, as well as having contributed to staff and business development.
Prior to starting her career in clinical data management, Ms. Goldberg worked at AT&T Long Lines for nine years, starting as a Fortran/COBOL/PL/1 programmer and leaving as the timeshare coordinator, where she coordinated all human resources programmers throughout the country. In addition, she designed, programmed and documented the Fortran-based Pension Calculation System, Key Events System, Graphic Arts Tracking System and other systems used in the traffic, engineering and human resources divisions of the company.
A member of the Society for Clinical Data Management (SCDM), Ms. Goldberg helped create the organizations second version of the industry-standard Good Clinical Data Management Practices (GCDMP). She is also a current member of the Drug Information Association (DIA). Ms. Goldberg has presented at national SCDM meetings, webinars and various other industry events.
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Director, Human Resources
In her role as Integrium’s Director of Human Resources, Regina is responsible for positioning Integrium as an employer of choice in the clinical research industry. She directs all recruiting efforts, designs and administers competitive compensation and benefits programs. Regina leads the development and implementation of HR-related policies, processes and programs and serves as the liaison between staff and management for company-wide HR communications.
Regina has a successful background in human resource management in the biopharmaceutical industry – encompassing over 12 years of experience. Her expertise lies in the creation and re-engineering of Human Resources departments. She has extensive multi-state knowledge of policies, practices and processes, compensation structures, recruiting, employee relations including legal compliance, organizational structure and building competitive programs.
Regina holds a Bachelors of Science degree in Sociology from St. Bonaventure University and a Certification in Human Resources Management from Bentley College.
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