Clinical Research Manager

Daniel C. Rosenberg, PMP *************@*****.***

***** **** ***** *****

Germantown, MD 20874

Cell: 240-***-****

www.linkedin.com/in/dcr66

Professional Profile

I have over 25 years of experience including public health and research psychology project management and in the computer sciences. My strengths include adaptability, tenacity, flexibility, thoroughness, team dynamics, and a strong work ethic. I am career-oriented and can work as an individual and in teams.

• Clinical research department management

• Client relations

• Staff supervision, training, mentoring, and positive reinforcement

• Training management (course design, implementation/delivery/maintenance)

• Protocol monitoring

• Data management

• Writing and editing

• Systems analysis

• Software development lifecycle management, waterfall, and agile methodologies

• Vendor management

• Statistical programming and analysis

Professional Accomplishments

Project Management, Training, Client Relations, and IT-Related Positions

• Relied upon for supervision and training of staff in all research and IT tasks for multiple projects and the acclimation of new staff to their positions, from the first week in every professional position, resulting in immediate increases in my colleagues’ and clients’ productivity and quality of work including multiple positions where this was not in my initially intended job description.

• Oversaw the development and implementation of a series of new standard operating procedures (SOPs) to ensure the highest quality of clinical research practices.

• Oversaw the requirements gathering, development, and initial implementation of a Clinical Trials Management System to improve program efficiency by at least 10%.

• Created a Microsoft PowerPoint training interactive seminar designed for state and local public health agencies in North Carolina that resulted in the improvement of the management and presentation of their community health data.

• Received consistently high ratings as a course instructor at two universities and as a corporate trainer.

• Received Employee of the Month awards from both employers who offered these awards for outstanding service and contribution to our clients.

• Resolved multiple urgent IT situations by being able to communicate with IT staff and stakeholders in ways each person understands.

• Discovered a major security flaw while testing an industry-leading electronic data capture (EDC) software package.

• Filled four critical staff vacancies in less than 30 days by expanding employer’s existing resources.

Daniel C. Rosenberg, PMP• *************@*****.*** Page 2 of 7 Statistical Programming

• Created, maintained, and reviewed hundreds of SAS programs for reporting all aspects of research data, and health and vital statistics, including reports adopted by multiple projects at one corporation.

• Provided statistical analysis for multiple reports and publications, including three publications in peer-reviewed journals as sole statistician. Therapeutic Groups

• Allergy, Autism, Diabetes, Infectious Disease, Neurology, Oncology, Ophthalmology Work History

Sabbatical 2/2018 – Present

Chief of Clinical Research Management 5/2016 – 2/2018 The Henry M. Jackson Foundation for the Advancement of Military Medicine, Rockville, MD

• Provide expertise and knowledge in the development and execution of complex multicenter clinical studies for all seven research areas of the Uniformed Services University (USU) Infectious Disease Clinical Research Program (IDCRP) with a particular focus on FDA-regulated clinical trials, while supervising and mentoring the Program’s Clinical Research Management (CRM) staff.

• Ensure operational success and timely accomplishment of protocol goals through effective leadership, management, and proactive identification and resolution of systems-based issues; conduct regular Research Area Review meetings to provide information to Program leadership; maintain knowledge and awareness of all IDCRP protocols and related documents.

• Proactively identify and implement opportunities for standardization and best practices across the IDCRP network related to protocol development, documentation, and execution; enhance metrics-informed management of protocols within the IDCRP, including management of the development, implementation, and training for the IDCRP Clinical Trials Management System (CTMS).

• Ensure Program level consistency in protocol management and execution in accordance with Good Clinical Practice guidelines and other applicable regulations.

• Develop and maintain clinical research and regulatory training materials related to the overall conduct of protocols; lead teams of CRMs, Clinical Research Coordinators (CRCs), regulatory affairs personnel, and others to prepare these materials; oversee and provide initial and refresher training to new and existing employees, as well as to extramural personnel; ensure documentation of training is maintained and available; oversee protocol- specific training activities and documentation.

• Oversee and manage development and maintenance of SOPs, ensuring availability, training, and documentation of compliance; coordinate with Data Coordination Center (DCC) Chief and others who have domain specific SOPs to ensure availability, training, and documentation of compliance.

• Supervise Program Regulatory Affairs Specialist; oversee and manage regulatory compliance processes.

• Responsible for effective communication, coordination, and management of IDCRP clinical research operations and regulatory matters with PCC, DCC, and site teams, Research Area and protocol teams, USU Human Subjects Daniel C. Rosenberg, PMP• *************@*****.*** Page 3 of 7 Protection Program, Institutional Review Board, protocol monitors, sponsors, auditors, and others as appropriate.

• Screen, interview, and select applicants for CRM positions and assist with the same process for non-CRM Program positions.

Clinical Trials Consultant 5/2015 – 5/2016

Various Short-Term Assignments

• Provide protocol, data management, and EDC systems support for a variety of projects as a short-term consultant.

Research Project Director 1/2007 – 4/2015

The EMMES Corporation, Rockville, MD

• Provide advanced support in senior roles for multiple projects. Interface daily with clients and partners to ensure the continuous and proper implementation of protocols at all sites.

• Supervise and mentor staff in all research and IT tasks, including clinical trials data management, protocol monitoring, software development lifecycle, SAS programming, and using all proprietary software. Develop and implement training materials for clinical trials management and protocol implementation

(in-person and web-based).

• Contributing author, reviewer, and editor of clinical and systems manuals of procedures, protocols, informed consents, case report forms, and project and corporate standard operating procedures. Draft, edit, and manage regulatory documents. Delegate associated tasks to project staff and communicate with clients and partners to ensure all project documents are comprehensive and comprehendible.

• Coordinate all central and local lab activities. Act as protocol-interpretation contact for clinic and laboratory staff to ensure the safety of participants and accuracy of data. Ensure procedures are implemented the same at all clinical and lab sites.

• Oversee clinical investigational product activities for multiple protocols including vendor selection, supply planning, packaging, labeling, ordering, distribution, storage, returns, and monitoring.

• Liaison between IT, project staff, partners, and clients. Ensure mutual understanding concerning technical requirements, timelines, functionality, and new developments. Manage project's software development lifecycle for proprietary applications from requirements gathering to end-user support

(including developing schedules, defining milestones, ensuring resource availability, requirements writing, maintaining comprehensive documentation in accordance with corporate SOPs, and ensuring good practices).

• Manage development and maintenance of complex relational databases. Triage and manage end-user support issues for software, databases, and web sites.

• Ensure the maintenance of systems security policies and procedures. Prioritize and manage project technical issues and ensure timely completion. Review project information management needs and provide efficient and economical solutions.

• Provide data management and statistical programming solutions using SAS. Analyze and report trial data for various purposes including annual meetings, data safety committees, conferences, and client review. Daniel C. Rosenberg, PMP• *************@*****.*** Page 4 of 7 Research Associate / Project Manager 8/2002 – 1/2007 George Washington University Biostatistics Center, Rockville, MD

• Manage National Institutes of Health (NIH) funded medical trials at study’s coordinating center. Interface directly with clients to ensure all needs are met and ensure the safety of participants. Oversee staff activities to ensure timely completion of quality deliverables.

• Train study personnel on study procedures, website, and software.

• Contributing author and editor of study protocol, manuals of procedures, patient brochure, and all study documents. Primary author, editor, and manager of all regulatory documents. Develop study forms for clinic use and data collection.

• Software development lifecycle contributor for corporate projects and manage project-specific systems development.

• Provide data management and statistical programming solutions using SAS. Review and code adverse events. Provide trial data and adverse events reports for various purposes.

• Collaborate with clients and partners at 28 clinical centers in North America to ensure that all clinic and laboratory needs are met.

• Develop request for proposals for study product and study device. Primary contact and manager of study product and study device contracts, including oversight of contractor performance.

• Conduct meetings with study staff. Organize study conferences and formal training meetings.

Project Director 9/2001 – 8/2002

State of North Carolina, State Center for Health Statistics, Raleigh, NC

• Short-term position to direct a statewide initiative funded by the Centers for Disease Control and Prevention (CDC) to enhance the capacity of state and local public health agencies to use data in program management and policy development. Manage all project activities, staff, and budget.

• Design data collection and evaluation protocols for community assessment and improvement activities.

• Perform statistical analyses using SAS to track local health status and to evaluate the effectiveness of community-based health improvement programs and policies.

• Prepare project reports, studies, presentations, and grant proposals.

• Provide training and technical assistance to public health professionals regarding the collection, analysis, interpretation, and use of quantitative and qualitative data.

• Employee of the Month, May 2002 for outstanding service to our clients. Research Assistant 7/1998 – 8/2001

North Carolina State University, Raleigh, NC

Temporary 5/1997 – 7/1998

Various Short-Term Assignments

Teaching Assistant 8/1996 – 5/1997

George Mason University, Fairfax, VA

Daniel C. Rosenberg, PMP• *************@*****.*** Page 5 of 7 Project Analyst / Senior Documentation Specialist / Instructor 9/1992 – 5/1998 Global Associates, Ltd., Falls Church, VA

• Provide on- and off-site customer support and training for Government clients located at the Office of Naval Research, Program Executive Office, USDA Forest Service, and the Pentagon.

• Provide conference management for both internal and external clients ranging 5 to 60 attendees. Use groupware technography skills to aid conference participants in decision-making and document preparation.

• Run statistical analysis on results tabulated from complex Government surveys.

• Produce various documents and briefs integrating graphics and text from multiple sources, including technical editing and writing.

• Provide computer training and technical support for 60-user office including network administration, system troubleshooting, and repair.

• Provide support and analysis for various Naval Space and Warfare Command surveillance projects.

• Provide paste-up, basic security procedures, team management, and the production of high quality results on tight deadlines.

• Super Employee of the Month, June 1994 for outstanding contribution to our clients.

Independent Contract Worker 7/1991 – 9/1992

Various Short-Term Assignments

Held various short-term contract positions in the field of IT systems support. Technical Specialist / Programmer / Systems Analyst 8/1988 – 7/1991 AmerInd, Inc., Alexandria, VA

• Train employees and clients on the use and care of both computers and software through formal classes and one-on-one support.

• Work for Naval Military Personnel Command (NMPC) included: design, model, and develop customer support systems; provide documentation; graphics support; analysis and design of database and printed information with spreadsheet development; hardware and software inventory control; and workstation setup.

• Primary producer of graphics for company briefs and proposals.

• Graphics consultant for other company divisions.

• Provide LAN administration, software inventory, and configuration management.

Daniel C. Rosenberg, PMP• *************@*****.*** Page 6 of 7 Relevant Volunteer Experience

President / Vice President / Past President / At-Large Board Member 2004 – 2009 Congregation Or Chadash, Damascus, MD

• Past President (2008–2009), President (2007–2008), 1st Vice President (2006–2007), 2nd Vice President (2005–2006), and At-Large Board Member (2004–2005).

• Supervised four professional staff members from May 2006 through May 2008. Handled staff and staff-member relations.

• Developed new policies and programs.

• Managed all Congregation priority and confidential issues with fellow Officers.

• Oversaw and contributed to several fundraising events.

• Chaired and co-chaired Congregation Board meetings. Education

M.S. Psychology (Developmental concentration with a focus on Adult Development, and Social minor)

North Carolina State University, Raleigh, NC 5/2003 M.A. Psychology (Life-Span Development with a focus on Child Development) George Mason University, Fairfax, VA 5/1997

B.S. Computer Science

College of William and Mary, Williamsburg, VA 5/1988 Certification

Project Management Professional (PMP)

Project Management Institute 6/2015

Publications

Peters, B., Williams, K. C., Gorrindo, P., Rosenberg, D., Lee, E. B., Levitt, P., and Veenstra- VanderWeele, J. (2014). Rigid–Compulsive Behaviors are Associated with Mixed Bowel Symptoms in Autism Spectrum Disorder. Journal of Autism and Developmental Disorders. 44(6), 1425–1432.

Mazurek, M. O., Vasa, R. A., Kalb, L. G., Kanne, S. M., Rosenberg, D., Keefer, A., Murray, D. S., Freedman, B., & Lowery, L. A. (2013). Anxiety, Sensory Over-Responsivity, and Gastrointestinal Problems in Children with Autism Spectrum Disorders. Journal of Abnormal Child Psychology. 41(1), 165–176.

Sikora, D. M., Vora, P., Coury, D. M., & Rosenberg, D (2012). Attention-Deficit/Hyperactivity Disorder Symptoms, Adaptive Functioning, and Quality of Life in Children With Autism Spectrum Disorder. Pediatrics. 130, S91–S97.

Hess, T. M., Germain, C. M., Rosenberg, D. C., Leclerc, C. M., & Hodges, E. A. (2005). Aging- related selectivity and susceptibility to irrelevant affective information in the construction of attitudes. Aging, Neuropsychology, and Cognition, 12, 149–174. Rosenberg, D. C., & Buescher, P. A. (2002). The association of maternal smoking with infant mortality and low birth weight in North Carolina, 1999. SCHS Studies, No 135. Daniel C. Rosenberg, PMP• *************@*****.*** Page 7 of 7 Rosenberg, D. C., & Buescher, P. A. (2002). Years of potential life lost by sex, race, and ethnicity: North Carolina, 2000. SCHS Studies, No 130. Hess, T. M., Rosenberg, D. C., & Waters, S. J. (2001). Motivation and representational processes in adulthood: The effects of social accountability and information relevance. Psychology and Aging, 16, 629–642.

Rosenberg, D. C., Willson-Quayle, A., & Pasnak, R. (2000). A preliminary test of the effects of cognitive ability, experience, and teaching methods on verbal analogy test scores. Psychological Reports: Perceptual and Motor Skills, 90, 1261–1267. Papers and Posters Presented

D. Rosenberg, G. Tucker, I. Barrow (2011). A Web-Based Study Product Verification Utility for Blinded Treatment of Food Allergy Subjects. Contributed paper at the Society for Clinical Trials Annual Meeting, Vancouver, British Columbia.

The Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Intervention and Complications (EDIC) Research Group; Prepared by: B. Waberski, P. Cleary, D. Rosenberg, K. Klumpp, C. Martin (2006). Implementation of a Neurological Protocol in an Epidemiological Study of Patients with Type 1 Diabetes (T1D). Poster presentation at the Society for Clinical Trials Annual Meeting, Orlando, FL. Rosenberg, D. C. (August 2001). Effects of Aging and Endorser Likability on Reactions to Advertisements. Poster presentation at the Annual Convention of the American Psychological Association, San Francisco, CA.

Hess, T. M., Rosenberg, D. C., Waters, S. J., & Germain, C. (August 2001). Impact of Affective Responses on Attitudes: Aging and Motivational Influences. Paper presentation at the Annual Convention of the American Psychological Association, San Francisco, CA. Hess, T. M., Rosenberg, D. C., & Waters, S. J. (April 2000). Influences on the construction of social representations in adulthood. Poster presentation at the Cognitive Aging Conference, Atlanta, GA.

Hershey, D. A., Farrell, A. H., Collins, C., Allaire, J. C., & Rosenberg, D. C. (April 1996). Developmental differences in perceptions of wisdom. Poster presentation at the Cognitive Aging Conference, Atlanta, GA.

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