Kenneth R Milstead Email & Phone Number

Seattle, Washington, United States

Manage all InFocus Clinical Data Management, Biostatistics, and SAS programming activities and personnel.

New Orleans, Louisiana, United States

Manage teams responsible for Clinical Research Computer Systems, Clinical Trials Project Management, Clinical Operations, Computer Systems Validation, and Clinical Data Management for Yale clinical research activities.

New Orleans, Louisiana

Provide consulting services in Clinical Data Management (CDM) and SAS programming for clients in the pharmaceutical, biotechnology, and device industries. Projects include data management, SAS programming, SOP writing, and EDC system selection / configuration /validation / deployment.Perform all aspects of CDM from protocol development to database lock in both paper and EDC environments.Perform all business aspects of running a consultancy, including business development, proposal preparation, bid defense, and client management.ASSIST CLINICAL RESEARCH ORGANIZATION (CRO) CLIENTS WITH: - Improving delivery of CDM and Electronic Data Capture (EDC) services to Sponsor companies.- Development/optimization of Standard Operating Procedures (SOPs) and other processes.- Selection and implementation of appropriate technology.ASSIST SPONSOR CLIENTS WITH:- Selection/management of CROs and other vendors.- Development/optimization of SOPs and other internal processes.- Implementation of Clinical Data Standards (CDISC CDASH, SDTM, and ADaM).CLINICAL DATA MANAGEMENT- 30 years clinical research experience in the US, Canada, and Europe.- 27 years in phase I-IV clinical trials and patient registries.- Training, mentoring, and project/line management of Data Managers, SAS Programmers, and Monitors. - Management of both in-house and outsourced paper-based and EDC studiesSAS PROGRAMMING & VALIDATION:- Program and validate database conversions and data warehouses.- Create ISS/ISE datasets, CDISC SDTM/ADaM datasets, and other analysis files.- Program and validate Tables, Listings, and Figures.- Supervise and validate outsourced SAS programming projects.- Program and validate data edit checks for use in data management review.

New Orleans, Louisiana (Remote)

Served as Project Manager for a remote international team of 45 mid-to-upper-level professionals.

New Orleans, Louisiana (Remote)

Subcontracted as TransCelerate eSource Workstream Project Manager (above).

New Orleans, Louisiana (Remote)

Planned and implemented solutions within a customer service engagement (project) by providing expert guidance to customers and making recommendations about best practices for implementing technology.Provided business analysis, business area assessment, user needs analysis, and business system design as required by the project.Provided project leadership to guide customers and project team members.Ensured customer relationships were properly managed throughout project.

Greater Boston Area & New Orleans, Lousiana (Remote)

Provided Clinical Data Management consulting services to BioBridges clients.Much of my work involved creating or supporting new Clinical Data Management groups in small to mid-sized companies. I also assisted clients in meeting particular challenges in their clinical development process, including:- Coordinated CDM and SAS activities for client's first product regulatory submission,- Managed locking of research databases that faced particular challenges, and- Managed and coordinated the work of CROs and other vendors.

Cambridge, Massachusetts

Outcome is a Clinical Research Organization (CRO) and EDC vendor focused on phase IV/post-marketing studies and registries.Started and managed the Clinical Data Management (CDM) team at Outcome, including Clinical Data Managers, Clinical Research Associates (Monitors), and contract SAS Programmers. Supervised all Outcome work in these areas.Provided CDM, SAS programming, EDC development, and other clinical research expertise for both Outcome internal projects and client projects. Provided input to management team and to Business Development regarding data management aspects of project bids and existing contracts.Represented CDM/Monitoring/SAS Programming department at client audits, bid defenses, and investigator meetings.

Various Locations/Remote

Provided consulting services in clinical data management for various clients in the pharmaceutical, biotechnology, and device industries, as well as in academia. Performed all aspects of Clinical Data Management (CDM) tasks from protocol development to database lock in both paper and Electronic Data Capture (EDC) environments.Projects included data management, statistical analysis, SAS programming, computer validation, writing of SOPs, systems analysis, and training.

Rockville Centre, New York

Setup Clinical Data Management (CDM) functions in-house at Columbia. Managed CDM aspects of studies outsourced to Clinical Research Organizations (CROs). Interacted with Columbia staff and FDA regarding data queries from regulatory submissions. Performed CDM activities for clinical trials that resulted in the FDA approval of Crinone (vaginal progesterone) and other products.

New Orleans, Louisiana

Provided epidemiology and computer consulting services for a law firm involved in scientific/medical cases and for other clients in the New Orleans area.Performed clinical trials data management activities for two biotechnology companies in the Boston area.

Deerfield, Illinois

Performed data management activities for several organ transplantation clinical trials that resulted in FDA approval of Prograf (tacrolimus).

New Orleans, Louisiana

Coordinated all Quality Assurance activities for the Tulane-LSU AIDS Clinical Trials Unit (ACTU).Monitored clinical research activities of three sub-units.Served as liaison for ACTU and private industry clinical trials monitoring activities.

New Orleans, Louisiana

Performed data management activities for the Tulane-LSU AIDS Clinical Trials Unit.Completed case report forms for study visits.Promoted to Clinical Data Coordinator position in December 1991.

New Orleans, Louisiana

Performed data management and other research tasks (including medical writing) for an orthopedic medical practice.

Ut Mental Sciences Institute

Performed data management and other research tasks for study of aging in adults with Down syndrome.

Master Of Science (M.S.), Public Health (Epidemiology)

Activities and Societies: School of Public Health Representative on Student InterCouncil. US Public Health Service Traineeship. Courses.

Bachelor Of Arts (B.A.), Psychology/Political Science

Activities and Societies: Peer Health Advocates. UNICEF Campus Ambassador.

Participated In Deeds Project Oracle Training Program

Training in Oracle application development, including SQL, PL/SQL, and development of web applications.