Manager, Clinical Sciences at Veridex, LLC
Greater Philadelphia Area
- Current
-
- Manager, Clinical Sciences at Veridex, LLC
- Consultant (Self-employed)
- Past
-
- Sr. Director, Clinical Development at Immunicon Corporation
- Director, Clinical Affairs at Fujirebio Diagnostics, Inc.
- Advanced Research Specialist at UroCor, Inc.
- Corporal at United States Marine Corps Reserves
- Chemist at Halliburton NUS Environmental Corporation
- Student Research Assistant at Texas A&M College of Medicine
- Education
-
- Texas A&M University
- Recommended
-
5 people have recommended M. Craig - Connections
-
190
connections
- Industry
- Medical Devices
M. Craig Miller’s Summary
15+ Years Experience in:
Clinical trial management – early development and clinical registration studies
- Protocol development – including statistical plans and CRF design
- Site and CRO selection, contracting and management
- Data and regulatory documentation and monitoring
Biostatistics – study specific statistical analyses, including outcomes research
Clinical data management – medical devices and diagnostics
Regulatory submissions – medical devices and diagnostics
Manuscript writing and editing – co-author on over 50 peer reviewed manuscripts
Software - STATA (statistical analysis package), STATISTICA, nQuery Advisor, FreeLance Graphics, GraphPad Prism, Sigma Plot, Visual Basic for Applications, all Microsoft Office applications.
M. Craig Miller’s Specialties:
Biostatistics, data management, clinical trial design and management, preparation of clinical sections for regulatory submissions (medical devices & diagnostics), manuscript writing, presentation preparation, etc.
M. Craig Miller’s Experience
-
Manager, Clinical Sciences
Veridex, LLC
(Medical Devices industry)
August 2008 — Present (1 year 5 months)
Manage and/or assist in management of overall operational plan of clinical and research studies including project planning, protocol development, financial management, supply forecasting, site selection, resource management and CRO management.
Design and manage statistical aspects of protocol development including sample size, endpoints, and data analysis plans as well as assist in the development of database structure, format, and integrity for clinical development and research studies.
Perform statistical analyses of research and clinical trial databases, and assist in preparation of regulatory submissions (i.e. FDA, EU and Japan), internal and external presentations, and publications.
Provide and manage statistical analysis services for other departments within the organization.
Act as a cross functional liaison to ensure study plan, logistics, and work load align with the Clinical Services Laboratory and business development strategies (Pharma Services). -
Consultant
Self-employed
(Self-Employed; Biotechnology industry)
August 2001 — Present (8 years 5 months)
Provide consulting services on specified projects, including database construction, statistical analyses, algorithm development, manuscript preparation and review, and technical report preparation to the following institutions:
Fujirebio Diagnostics, Inc. (July 2006 – Present)
Immunicon Corporation (July 2005 – June 2006)
Robert Michaels Communications (January 2005 – June 2007)
Johns Hopkins Medical Institutions, Dept. of Urology (March 2002 – Present)
UroCor, Inc., a Division of Dianon Systems (August 2001 – December 2001) -
Sr. Director, Clinical Development
Immunicon Corporation
(Public Company; 51-200 employees; Medical Devices industry)
August 2001 — July 2008 (7 years )
Design, implement, coordinate and execute clinical research and development trials using Immunicon’s proprietary technology for the isolation, detection, enumeration and characterization of rare events in blood in patients with solid tumors.
Direct overall operational plan of clinical studies, including planning, protocol development, financial management, supply forecasting, site selection and management, and resource and CRO/CRA management.
Responsible for compilation and statistical analysis of data from clinical studies for inclusion in regulatory submissions, meeting abstracts and posters, manuscripts, marketing material, etc.
Review, evaluate and compile files and reports for direct inclusion in submissions including 510K and PMA applications and foreign registrations. Meet with regulatory agency personnel to obtain agreement on clinical trial study design and negotiate clearance/approval of pending applications. -
Director, Clinical Affairs
Fujirebio Diagnostics, Inc.
(Public Company; 51-200 employees; Biotechnology industry)
July 2005 — June 2006 (1 year )
Responsible for coordination and execution of all activities related to clinical studies for ongoing development projects. Ensure timely clinical development and coordination of all non-clinical studies in accordance with requirements for US and foreign regulatory submissions and registrations for new in-vitro diagnostics devices.
Review, evaluate and compile files and reports for direct inclusion in submissions including 510K and PMA applications and foreign registration documentation. Meet with regulatory agency personnel to obtain agreement on clinical trial study design and negotiate clearance/approval of pending applications.
Plan, develop and manage clinical studies, including protocols, CRFs, databases, sites and CROs, and budgets.
Responsible for compilation and analysis of data from clinical development and/or research studies for inclusion in regulatory submissions, meeting abstracts and posters, manuscripts, marketing material, etc. -
Advanced Research Specialist
UroCor, Inc.
(Public Company; 51-200 employees; UCOR; Hospital & Health Care industry)
November 1992 — July 2001 (8 years 9 months)
Responsible for operation and supervision of R&D Image & Computational Laboratory and personnel assigned to lab and for management and statistical analysis of all R&D databases (i.e. patient related clinical follow-up, serum bank, developmental product, etc.) and special projects (i.e. Government grants and contracts).
Assist in development of new and innovative products in the detection, prognosis, and monitoring of urologic diseases (mainly prostate and bladder cancer). Test and troubleshoot new and developmental software programs for use in these efforts.
Responsible for training of personnel and technical transfer of new methodologies to Operations division of company.
Prepare and present reports and presentation materials for upper level management, external academic & scientific collaborators, and national and regional scientific meetings (i.e. AACR, AUA, AJCC, etc.). Assist in the preparation of departmental budget, protective patent applications, and manuscripts. -
Corporal
United States Marine Corps Reserves
(Government Agency; Military industry)
June 1988 — April 1993 (4 years 11 months)
Served initially as a Field Artillery Radar Operator at the Naval Air Station in Grand Prairie, Texas where I held a top-secret security clearance. Responsible for operation and maintenance of mobile radar equipment for the detection, tracking, and establishment of positioning of incoming artillery attacks.
Transferred to Ordinance Maintenance Company in Waco, Texas and served as a Supply Chief, responsible for issuing and maintaining the unit’s equipment and warehouse.
Transferred to Fox Artillery Battery in Oklahoma City, Oklahoma and served as an Ammo Driver, responsible for delivery of artillery rounds to firing lines.
Received an honorable discharge in April of 1993. -
Chemist
Halliburton NUS Environmental Corporation
(Public Company; 51-200 employees; Environmental Services industry)
August 1991 — October 1992 (1 year 3 months)
Performed quantitative analyses of volatile and extractable organics in hazardous waste samples by gas chromatography using ECD, FID, NP Bead, PID, HALL, and Ion Trap detectors.
Interpreted and reported results of analyses to appropriate units. Demonstrated proficiency through a rigorous quality control / assurance program.
Operated and maintained Hewlett-Packard and Varian GC's and auto-samplers. Also operated and maintained a Finnigan MAT Ion Trap.
Strictly adhered to EPA and ASTM standards and methods, as well as developed and implemented new methods. -
Student Research Assistant
Texas A&M College of Medicine
(Educational Institution; Research industry)
October 1989 — August 1991 (1 year 11 months)
Responsible for preparation and sterilization of media, solutions, and equipment for the laboratory.
Performed protein assays, western blots, gel electrophoresis, DNA recombinancy, cloning, sequencing, and purification work, as well as learning various culturing techniques.
Repeated a portion of the experiments for a Ph.D. project to verify the accuracy of the data.
M. Craig Miller’s Education
-
Texas A&M University
BS , Biochemistry , 1987 — 1991
