PROJECT MANAGEMENT / CLINICAL OPERATIONS & DEVELOPMENT 
PERSONAL PROFILE
- 24 years in clinical development of investigational therapeutic and diagnostic products.
EXPERTISE
Clinical Operations; Monitoring; Clinical Research Line Management; Domestic and International Phase 1-4 Pharmaceutical Studies and Pilot, Pivotal, and Post-market Medical Device Studies; Investigational Site Feasibility and Management; Training of Investigators, Study Coordinators, and Study Monitors; GCP/ICH Auditing; Vendor Qualification and Management; Institutional Review Board (IRB) Investigator/Site Assessments; Project Management; Clinical Trial Documentation (i.e., protocols, case report forms [CRFs], informed consent documents, investigator brochures, instructions for use); Reports for Regulatory Submissions; Client Infrastructure and Quality Systems (i.e., standard operating procedures [SOPs], work instructions, project plans, and tracking databases); IND, IDE, NDA, PMA, and 510(k) Submissions.
Registered Quality Assurance Professional GCP 2012, Society of Quality Assurance Certified Clinical Research Associate 2009, Association of Clinical Research Professionals; BA in Chemistry, Bates College.
PROFESSIONAL EXPERIENCE
Project and Clinical Operations Management
Assure quality, on-time deliverables and on-budget performance. Provide operational management for domestic and international clinical trial programs. Coordinate activities of multi-disciplinary project teams and external vendors, including selection, contract negotiations, and management. Assure compliance with Sponsor and project requirements. Perform ongoing project status and budget tracking, including evaluating and implementing document management systems (i.e., CTMS, EDC, eTMF). Develop and implement monitoring plans, co-monitoring plans, and communication plans and site visit/communication report templates. Define and monitor clinical operations and deliverables metrics, and implement remediation as required. Compose protocols, case report forms, informed consent documents, investigator brochures, and edit specifications. Create and implement subject recruitment strategies, site feasibility, and management, including PI and KOL relationships. Negotiate investigator agreements and administer investigator payments. Organize and present at Investigator Meetings and other project-related events. Develop references and guidelines for study conduct and audit tools for evaluating protocol compliance. Manage trials in support of marketing applications (i.e., NDA, PMA). Develop and implement SOPs (standard operating procedures). Liaise with regulatory and quality assurance teams to assure GCP compliance of clinical studies.
Monitoring
Qualify, initiate, monitor, and close clinical trial sites to assure adherence to protocol, SOPs, and GCP/ICH and other applicable regulations. Conduct source document review and verify accuracy of collected study data (i.e., CRFs). Assess regulatory compliance and essential document maintenance at clinical trial sites. Maintain investigational product accountability. Document accurate and timely Sponsor/site communications and site visit reports. Utilize Remote Data Entry/Electronic Data Capture systems (i.e., Phase Forward/InForm, sponsor/CRO proprietary systems) and Clinical Trial Management Systems (i.e., IMPACT, Siebel Clinical). Liaise with Data Management to assure complete and accurate resolution of queries, and to review data listings.
Founder/Principal Consultant, LWY Consulting Inc. d/b/a Panacea Clinical Research
Project Manager & Lead Clinical Research Associate, Paragon Biomedical, Inc.
Clinical Project Leader, ImmunoGen, Inc.
Clinical Research Associate, Quintiles, Inc.