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Clinical Study Manager

Location:
Windsor, WI, 53598
Posted:
February 26, 2016

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Resume:

THOMAS IAN RIDD **** Highland Drive • Windsor, Wisconsin 53598

actphu@r.postjobfree.com 608-***-**** (H) • 608-***-**** (C)

BACKGROUND SUMMARY

Study Director/Clinical Studies Manager with extensive experience in diverse areas of pharmaceutical research and in vitro diagnostics devices. Proven track record of developing protocols and establishing methodologies that results in quality data and reporting. Strong project management skills that contribute to optimal product outcomes in alignment with the company’s requirements.

PROFESSIONAL EXPERIENCE

LUMINEX CORPORATION, Madison, WI

Clinical Studies Manager, In Vitro Diagnostic Devices February 2013 to December 2015

Served as a clinical study manager managing all clinical study activities at Luminex.

Coordinated all aspects of clinical studies, qualification of clinical sites, training of site operators, monitoring (remote and on-site) of the clinical study activities and performing close out site visits at completion of the clinical trials.

Facilitated writing of clinical study protocols and study related documentation (CRF’s, Site presentations and clinical data forms) in compliance with GCP and ICH guidelines.

Performed critical review of data, writing of reports, SOPs and other documents.

Effectively managed via on site and remote monitoring 3 clinical in vitro diagnostic device trials to FDA submission with the initial IVD device/assay just receiving FDA clearance.

Acted as Liaison for the clinical affairs group to partner with research and product development to develop a strategy for the next wave of assays.

COVANCE LABORATORIES INC., Madison, WI

Lead Study Director, Drug Metabolism 2011 to 2012

Expanded the use of Taqman technology to include the evaluation of various genes in mice and monkey blood.

Provided expert consultation on all aspects of ex-vivo cytochrome P450 drug metabolism projects to toxicology staff and pharmaceutical clients, providing recommendations that enhanced drug development and increased revenue 50% in one year.

Staff Scientist/Senior Study Director, Drug Metabolism 2000 to 2011

Served as study director managing all aspects of Good Laboratory Practice studies within the in vitro drug metabolism department, establishing protocols for research that ensured quality data within project deadlines.

Established financial and pricing structure for laboratory projects, developing cost effective proposals to win business opportunities and ensure client retention.

Effectively managed 30 diverse projects simultaneously, reviewing data and providing documentation that enhanced issue resolution, data evaluation/interpretation and reporting needed for timely and effective decision making.

Acted as liaison for the in vitro drug metabolism department to partner with study directors from toxicology department, expanding client base 150% and significantly increasing revenue.

Managed in vitro method development projects and enhanced standard industry assays to expand market opportunities and meet client requirements.

Initiated and presented training for in vitro chemists to improve data quality and documentation methods, increasing efficiency and exceeding study timelines.

Recommended the purchase and managed installation of a Hamilton Star plus Robotic system to enable faster throughput of in vitro assays and increase profitability.

Led team of chemists in transferring manual cytochrome P450 IC50 Inhibition assays to robotic system, streamlining operations and reducing costs.

Facilitated all aspects of validation for new assays, including literature review, study design, protocol development and data collection to ensure accurate and consistent reporting methods.

Collaborated with study coordinator group to streamlined report writing process, expediting information needed by clients to gain FDA approval for new product development.

Established new service line for in vitro department through purchase of an Applied Biosystems 7900 HT PCR instrument that provided entry to new markets.

Acted as team leader for the validation of mRNA gene expression in rat and dog liver samples and human/rat hepatocytes.

Study Director, Drug Metabolism, Harrogate, UK 1997 to 2000

Managed all aspects of Good Laboratory Practice (GLP) studies within the in vitro department, including client management, development and site visits to ensure quality/ timely reporting and increased revenue.

Senior Experimental Officer, Drug Metabolism, Harrogate, UK Prior to 1997

TEXACO OIL REFINERY, Milford Haven, Pembrokeshire, UK

Industrial Placement

EDUCATION

PhD, Chemistry, University of Surrey, Guildford, United Kingdom

MS, Toxicology, University of Surrey, Guildford, United Kingdom

BS, Biochemistry, University of Wales, Swansea, United Kingdom

TECHNICAL SKILLS

Win Non Lin, Sigma Plot, Grafit, Word, Excel, Project, PowerPoint,

PROFESSIONAL DEVELOPMENT

Project Management

Advanced Project Management

Leadership Development

Managing Difficult People

Interviewing Skills

PROFESSIONAL AFFILIATIONS

Member, ISSX

Licensed Wisconsin Youth Soccer Coach

ADDITIONAL EXPERIENCE

Event Planner – Coordinate all aspects of golf trips for groups of 4 to 8 people throughout the United Kingdom and Ireland, including travel, accommodations, scheduling and touring.

PUBLICATIONS

Luo, G., Gohdes, M., Hollfelder, S., Engh, N., Schicker, M., Thorson, H., Campbell, K., Christie, E., Jung, B., Horabik, K., Lund, E., Lee, D., LiuPerez, L., Watney, A., Duffy, A., Zuvon, J., Erickson, D., Fitzsimmons, M., Ridd, I., Koganti, A., Bashir, M., Struble, C., Ridgewell, R., “Factors Influencing Metabolism of 7-Ethoxycoumarin in Isolated Hepatocytes from Six Species.” ISSX 2009

Cheung, Y., Lewis, D.F.V., Ridd, T.I., Ioannides, C., and Gray, T.J.B., “Diaminonaphthalenes and Related Aminocompounds: Mutagenicity, CYP1A Induction and Interaction with the Ah Receptor,” Toxicology, 118 (115-127), 1997.

John M Pratt, T. Ian Ridd, and Laurence J King “Activation of Hydrogen Peroxide by P450: Evidence that the Hydroxylating Intermediate is Iron (III)-co-ordinated Hydrogen Peroxide and not the Ferryl Fe03+ Complex,” J. Chem. Soc., Chem Commun, 22 (2297-2298), 1995



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