- 21 years in database management.
Certified Clinical Data Management Professional; Oncology; Project Management; CRO and Vendor Management; Process Improvements; SOP Development; Data/Vendor Management Plans; Standards Creation and Management; Contracts and Financial Analytics; Process Improvement; GCP, ICH, and GMP Compliance; Cross-Departmental Trainer of Multiple Systems and Compliance Topics; Branding and Negotiation; Public Speaking and Communications.
Principal Consultant, Adaptive Clinical Consulting, LLC
Provides individual, flexible, high quality guidance and hands-on support for biotech and pharma drug industry. Specializes in strategy, contract negotiation, and tactical execution of Clinical Data Management, Training and eLearning Development, Vendor and Alliance Management, Quality Assurance, Documentation, and Compliance activities.
Director, Data Management, Allos Therapeutics, Inc.
Led diverse team of direct reports and devised and integrated department’s strategic path forward. Authored numerous Standard Operating Procedures (SOPs) and Work Instructions with clear, consistent procedural messages and regulatory compliance while streamlining processes within and across functional areas. Used innovative and critical thinking to evaluate project and process ROI to assess point of diminishing return. Reviewed SOWs, budgets, charters, and other study documents to intensify sponsor value and discern potential challenges to quality and/or completion. Ensured data management milestones aligned with timelines, FDA and ICH guidelines, and SOPs. Identified potential issues/risks and worked with study team to forge mutually acceptable and executable paths forward. Reviewed clinical study reports (CSRs), tables, listings, and forms (TLFs), clinical monitoring plans, and investigational brochures. Contributed to the writing of safety narratives as needed. Hands-on lead data manager for multiple in-house and outsourced Phase 1 – 3 oncology studies, including data review, eCRF and edit check specification, CRF design, and documentation development and approval. Drove agendas for study team meetings, capitalizing on agreements to unify functional areas, while formulating opportunities to minimize and manage conflict. Deployed resources in accordance with available budget and shifting priorities. Forecasted future staffing needs along with potential pinch points to inform upper management of excessive risk while illustrating multi-option plans for mitigation. Advised outsourcing division on contract language and deliverables.
Product Lifecycle Management Team, AMGEN, Inc.
Executed cross-functional assessment of existing and potential Manufacturing Procedures (MPs) requirements related to product lifecycle in a multi-host facility within a GMP environment which resulted in a 20% reduction in document-related CAPAs. A manufacturing specialist, directed team in consistent, centralized approach to document revision/creation. Created job aids to drive efficient system use by manufacturing staff to access document and project information. Instituted quick reference guides to support site management’s rapid extraction of project metrics and data for reporting in executive management meetings. Created a Bill of Documents mapping dozens of primary product Manufacturing Procedures (MPs) and supportive MPs. Edited safety newsletter.