CLINICAL OPERATIONS 
PERSONAL PROFILE
- 16 years, mostly in clinical operations.
EXPERTISE
Clinical Trials Management; Compliance; Protocol Synopsis/Development; Project Budgets and Timelines; Management of Field CRAs and Internal Project Coordinators; Vendor Selection, Oversight, and Audit (CROs, labs, imaging, drug distribution); Patient Recruitment and Retention; SAEs and Regulatory Reporting; Site Feasibility, Selection, and Management; Monitor Training and Mentoring; Close-Out Activities; Project Management; Medical Writing/Editing; Start-Up Experience; Cross-Functional Project Team Leadership; Collaboration; Therapeutic Areas (Diabetes, Ovarian Cancer, Non-small Cell Lung Cancer, Hepatitis C with HIV, HCV in special populations, Bipolar/Depression and Hypercholesterolemia).
PROFESSIONAL EXPERIENCE
Senior Clinical Study Manager (Oncology), Takeda, Inc.
Manage oncology clinical studies according to global regulatory requirements (including but not limited to US CFR, EU CTD, and ICH GCP) and SOPs. Lead cross-functional study execution team, including corporate functions, strategic partners, and vendors to ensure study goals are met on time and within budget. Oversee SAE case processing, including receipt, tracking, escalation, and follow-up of SAEs. Meet weekly with medical monitor to review all safety issues considered serious and/or related to study drug. Contribute to protocol synopsis development and to Clinical Study Plan development, including Clinical Operations feasibility assessments. Lead the cross-functional protocol development process, including responsibility for protocol amendments and administrative changes.
Associate Director Clinical Operations, Vertex Pharmaceuticals, Inc.
Provide training to clinical project managers on study conduct and execution and MS Project timelines and study budget trackers. Oversight of Study Execution teams. Manage oversight of outsourced services to vendors as well as project and resource issues. Drive implementation of process improvements to enhance GC compliance, efficiency, and productivity. Ensure internal compliance with Clinical Development SOPs, guidelines, and corporate compliance policies related to clinical trial conduct aspects of GCPs.
Senior Clinical Project Manager, Vertex Pharmaceuticals, Inc.
Managed all aspects of Phase 2-4 global HCV studies. Project management role included vendor and full-service CRO management; establishment of CRO Key Performance Indicators; writing and contributing to protocols, ICFs, and case report forms; and other project-associated plans and manuals. Responsible for Study Execution Team conduct and management while providing strategic oversight, delivery of project timelines within assigned clinical project budgets, and communicating key project risks including out-of-scope activities.
Project Manager, Johnson & Johnson
Along with medical writing and project lead responsibilities, managed spine studies throughout the US, Australia, and South Korea, and trained new CRAs on qualification, initiation, interim, and close-out monitoring visits. Served as a mentor for project assistants working toward career development as CRA. Managed vendor RFPs and selection, budget creation and negotiation with sites and vendors, Investigator recruitment, and enrollment and retention plans. Managed an internal safety program. Worked with data management and biostats to create and review listings generated from collected data and co-presented interim results at Investigator meeting. Provided extensive trip report review for other project managers.