Colleen Hoke
Colleen Hoke brings her expert skills as a leader, communicator, collaborator and operator with over 25 years of successful experience in the development, management, and staffing of clinical research organizations. She has contributed to best practice standards for the Association of Clinical Pharmacology Units (ACPU) and is a graduate of the Wharton School of Business Executive Leadership program. She has served in senior positions with international world-class clinical research organizations.
Ms. Hoke has held executive and leadership positions for Clinical Research Organizations, specialty providers and healthcare entities. She helped build the nation’s largest public, advanced cancer clinical trials network, both in terms of locations and research patient accrual and publications in the 1990s. She then built one of the largest single site clinical pharmacology research units in North America (250 beds). She spear-headed the sale of the business in 2006. Post-acquisition by a world class top tier Clinical Research Organization, Ms. Hoke served as the global GM and Chief Operating Officer for clinical research operations, exceeding key performance indicators and overseeing operations as well as agency (e.g. FDA) and internal site audits. Additional functional areas of oversight expertise include: human resources, finance, business development (all aspects), resource scheduling, medical and technical staff management, and development and implementation of Six Sigma Initiatives and site harmonization activities. She also has a deep understanding of developing annual strategic plans, strategic relationship growth and management tactical plans, expansion of services lines.
She has also served in senior positions responsible for business development and as a business oversight officer for a fast growth niche biomarker lab and a generics formulation specialty CRO.
Ms. Hoke, building on her industry experience has now moved to clinical research consulting. Consulting roles have included supporting clinical trial system management, infrastructure growth, site development projects, compliance audit recommendations and research site work instruction standards development/implementation.
