I work with leading medical and statistical researchers in oncology to design sophisticated and pragmatic clinical trials in oncology. I work with an exceptional data management team to execute these trials, and a programming team that delivers insights rapidly.

• Strategic lead for EHR-enhanced studies, patient recruitment, digital campaigns, website development, and patient travel.• Initiated and established partnerships with 5 different enterprises, from site networks to software developers.• Established protocol development service offering.

• Product Owner for a software platform and research network of EHR users, allowing healthcare practices to participate in Real World, prospective, observational research• Market Assessment, Product Design, Inception, and Roadmap• Develop partnerships with CROs, Sponsors, and technology providers to provide end-to-end research solutions.• Awarded a Co-Development Grant from the Microsoft Commercial Software Engineering (CSE) team. Microsoft appointed a team of 12 engineers and specialists for 6 months to co-develop the data platform. I provided the vision, closed the arrangement, and helped lead the engagement.

• Launched a US-practice in technology consulting for clinical development• Developed an eClinical Roadmap for emerging and mid-tier research sponsors enabling a shift to from full-service contracts to functional service providers (FSPs)• Developed a Risk-Based Monitoring Adoption package for emerging and mid-tier pharma.

• Executive with dual responsibilities: Establish and run a Late Phase Research Service and oversee eClinical technology• Led business development activities; achieved 21 m USD in sales on a 15M USD target in 2016• Oversee all clinical systems: CTMS, EDC, IWRS, eTMF• Responsible for in-house software development and partnering with software vendors• Lead the specification, development, marketing, and implementation of a next generation EDC system, capable of secure, direct patient contact, sophisticated data integration, advanced reporting, and eSource-ready.

Oversaw Global Statistics, Programming, Data Management, HEOR, and Medical Writing for Late-Stage Research, both interventional and observational.

• Devised and executed methods for collecting real-world outcomes and clinical data, performing analytics, and publishing the results• Built a full-service data management group, a diverse group of statisticians, a medical writing group, and an exceptional team of programmers• Collaborate with epidemiologists, medical experts, applications developers, and a diverse group of vendors• Led integration of North American Biometrics department with French office• Introduced metrics, standards, key performance indicators and accountability, resulting in no rework, and no missed timelines for 4 years in a row• Led EDC strategy and dramatically expanded EDC capability, including integrated ePRO (Electronic Patient Reported Outcomes), and EHR integration• Re-engineer site payment process and technology; led a multi-disciplinary and international team to develop process and requirements for site reimbursement• Developed a drug tracking system tuned for Compassionate Use and Expanded Access programs (EAPs)• Hired and coached new and incumbent managers, resulting in 0% voluntary turnover for 3 years• Developed Medical Writing Function, wrote SOPs, hired staff• Developed an internship program with the University of Kentucky and Eastern Kentucky University for Statistical programmers.

• Oversee Biostatistics, Data Management and Programming for Kendle Offices in Cincinnati, Chicago, Los Angeles, Durham, and Wilmington, NC - 240 employees• Accountable for the performance of key global studies, including a pivotal 3400 patient, 12 country EDC study• Exceeded revenue target (44m USD)

Program Leader for an enterprise document management system based on Documentum. (PRA eTMF 2.0) Conducted formal requirements gathering with a global team of diverse clinical development professionals. Lead a multi-functional team that perfomed complete SDLC, Development, and Training for this Part 11-compliant system. Also responsible for Quality Management, with a focus on Document Management Processes, Analysis and Reporting, and Regulatory Standard Operating Procedures.

Directed a 135-person Clinical Data Management operation. Centralized North American Operation, and participated in implementation of hosted EDC system, base on Datalabs XC (Now Clinphone EDC) with leadership of pricing and licensing fees.Focus on Change Management

Directed development of proposals for Clinical Development services, ranging from Regulatory submissions, Phase I - IV, including all services offered by the CRO.Lead Strategic discussions for clincial development, and developed processes and algorithms for costing.

Directed SAS programming, and electronic publishing in support of clinical trial reporting. Provided program management for eNDA and traditional NDA submissions.Managed Staff in New Jersey and Virginia, totalling 30 direct reports.Developed mature processes for data integration, submission QC, and integration of results within clinical study reports.

SAS programmer for Clinical Trials work. Made Tables, Graphs, Patient Profiles, Databases, the usual. Developed data integration methods for ISS/ISE submissions, wrote code that wrote code prior to the SAS macro language, built databases, stayed up late and had a blast.