Cherry Hill, New Jersey, United States
Implemented strategic marketing plans for patient enrollment and randomization, drug forcasting and resupply, and patient diary IVRS services. Responsible for the IVRS sales team rebuild. Recruited a team of six account executives. Launched a new service line IVRS Express Suite. Formed strategic alliance with other service provider to expand service capabilities to preserve client relationships while addressing current & future needs
Provide strategic direction for all of Covance drug development services (Phase I-IV, Labs, IVRS, ECGs & Health Economics) within select accounts. Customize service solutions to meet customer business initiatives, identify cross functional unit efficiencies by improving process, create/maintain key customer relationships, and introduce/expand additional Covance service offerings. Lead account executive team to drive strategic plan . Ensure overall customer satisfaction. Represent Covance entity by functioning as single point of contact across multiple service offerings.
Assist with protocol development and case report form design. Handle communications to investigation centers, data collection, data management/analysis, clinical inventory management, site selection, budget allotment, and patient follow-up. Accountable for the successful enrollment of more than 15,000 subjects under various specimen collection protocols.
Responsible for the field management of clinical research studies to assure compliance with FDA Regulations; pre-study site assessments, regular quality assurance audits, and investigator recruitment. Prepared FDA 1639 adverse event reports, assembled pre-study documentation, Maintained adequate study reports and medication supply at investigator sites, reviewed completed case report forms for accuracy vs. Clinical records; instructed each investigative staff regarding protocol requirements, reporting adverse events and patient selection; maintained in-house databases and files