- 14 years in pharmaceutical industry with 10+ years in clinical research and clinical trial management.
Full Scope Global Study Management; Clinical Research Operations (CRO) Management; Vendor Selection and Oversight; Budget and Timeline Management; Team Leadership and Training; Issue Management; Site Selection; Enrollment Models; Clinical Supply Forecasting and Management; Investigator, DMC, Vendor, and Other Study Meeting Planning and Implementation; Drafting Study Documents (Protocols, Study Plans, ICFs, EDC/Case Report Forms, Narratives, Clinical Study Reports, SOPs and Presentations); IxRS System Set-up; Data Review, Cleaning, and Database Lock; Site Management; and FDA Regulations, GCP, and ICH Requirements. Therapeutic Areas: Oncology (Phases 1-3 dose escalation, rollover, and QT studies, small molecule and immunology, solid tumors, NSCLC, ovarian, AML/MDS, CTCL, SLC, and ACC); Infectious Disease (Phase 3 global trial of Azole treatment in candidemia), and Kidney/Liver (Phase 3 FDA submission for transplants).
Clinical Research Consultant, SMW Consulting
Manages all aspects of clinical trials, cross-functional study teams, and vendors. Drafts protocols, amendments, study plans, clinical study reports, patient narratives, and other study documents. Performs clinical review and manages data capture including data entry, cleaning, and database lock. Plans and implements study, investigator, and Data Monitoring Committee (DMC) meetings. Prepares vendor requirements, project scope, timelines, and RFPs. Assesses feasibility, and site and country selections for clinical studies.
Clinical Project Management, Novella Clinical
As team leader, managed clinical trials, timelines, budgets, and client relationships. Drafted protocols, amendments, study plans, clinical study reports, and other study documents. Implemented electronic data capture systems, and managed data capture, entry, analysis, cleaning, and database lock. Defined training requirements to assure project compliance. Assisted with development of SOPs, internal processes, working practices, and quality assurance forms. Developed and delivered capability and proposal defense presentations.
Clinical Study Manager, Associate Clinical Study Manager, Astellas Pharma
Managed clinical studies in compliance with GCP/ICH guidelines and other regulatory requirements. Managed cross-functional teams and vendors. Maintained accurate study information in the Clinical Trial Management System (CTMS). Created and adhered to study timelines. Planned and conducted study, investigator, and Data Monitoring Committee (DMC) meetings. Drafted protocols, amendments, study plans, informed consent forms (ICF), clinical study reports (CSR), publications, and other study documents. Developed and performed study user acceptance testing (UAT) procedures. Designed and implemented quality systems and processes for investigative sites, vendors, and data. Prepared vendor requirements and project scope for RFPs. Assessed feasibility, and site and country selections. Managed data capture, cleaning, statistical analysis plan review, data analysis, and top line results. Ensured key study team deliverables. Prepared presentations for operational and therapeutic areas for internal and external study members.
Clinical Research Associate II, Clinical Research Associate I, Clinical Research Coordinator, OSI Pharmaceuticals
Coordinated and chaired investigator calls and vendor meetings. Drafted protocols, informed consent forms, case report forms (CRF) and instructions, monitoring plans, study-related materials, presentations, manuscripts, clinical study reports (CSR), standard operating procedures (SOPs), and 1572 forms. Conducted drug forecasting. Maintained clinical trial supplies. Responded to quality assurance audits. Developed and implemented enrollment boosting strategies. Participated in site selection and study implementation. Performed pre-study site visits, site initiation visits, routine monitoring visits for data collection, source data clarification, resolution of data discrepancies, study drug accountability, review of regulatory documents, and site closeout visits. Supported CRO, vendor, and contract CRA selection and management. Assisted CRO management of Phase 3 global study and site activation. Processed IP shipments and clinical site payments. Facilitated new equipment purchases. Managed vendors. Managed maintenance, calibrations, and repairs of GLP equipment. Facilitated service agreement process.
Professional Research Assistant, University of Colorado Health Sciences Center
Performed assays in proteomics lab. Trained in Mass Spectrometry, including MALDI, HPLC, and LC-MS/MS. Billed outside labs for training and laboratory instruments. Presented status reports for research projects.