Diane Miller Email and Phone Number

Create and advance the strategic vendor management plan driving global, complex, cross-functional process and productivity improvement projects for Development Operations. Lead the implementation of strategic sourcing and process improvement initiatives.Accountable for vendor performance and oversight across Clinical Operations and Data and Statistical Sciences.

Established a programmatic outsourcing service model.Developed business processes, KPIs, SOPs, performance expectations, communication pathways and training.Built governance framework and lead governance process fostering effective communication, oversight, alignment of expectations and issue resolution.

Primary business operations and relationship manager for multiple third party global strategic suppliers overseeing the effectiveness of quality systems across a dynamic portfolio of more than 200 active PI – PIV clinical trials. Drove business value by ensuring resourcing, timelines, quality and productivity deliverables were met. Monitored and reported performance metrics, identifying opportunities for continuous improvement. Managed budget of $120MM annually, for functional line and outsourced services.

Built and maintained strong vendor relationships through oversight, management of service level agreements and governance. Managed operational budget of $50MM..

Managed a team of twenty regionally based Clinical Research Associates. Actively provided support to direct reports helping them achieve their professional development goals. Ensured all required project deadlines and quality standards were met. Directed and balanced the distribution of resources across projects. Coordinated and conducted meetings for training and team building. Developed performance management plans and correlated individuals’ progress in periodic reviews.• Served as Lead Trainer and implemented documented training standards across all US Regions. • Maintained 98% retention.

Monitored sites in multiple therapeutic areas including Cardiovascular, Diabetes, CNS, Women's Health, and Osteoporosis. Assured sites were in compliance with FDA Regulations, Good Clinical Practices and Pfizer Standard Operating Procedures. Proficient in study start up, study in progress and study close out visits.

Research Quality Auditor (1995) Conducted the following types of audits: investigator site, clinical laboratory, CRO, data listings, systems and phase I unit facilities. Designed and implemented audit plans, issued reports and ensured compliance to corrective action plans. Clinical Research Associate (1992 -1995)Monitored clinical trials in urology ensuring quality and compliance. Contributed to developing protocols, case report forms, annual reports and clinical summaries.Research and Development Technician (1990 -1992)Developed and optimized Hepatitis C 1.0, 2.0 and Neutralization Enzyme Immunoassays. Traveled to customer sites to troubleshoot assay techniques, efficacy and instrumentation.