Quality Assurance Clinical

Clinical Quality Assurance

AREAS OF Experience

●Responsible for quality and compliance of clinical trials with applicable GCP

regulations, ICH GCP guidelines, Madrigal SOPs, and current industry standards and best practices.

●Clinical Quality Assurance Auditing; Vendor, Investigative Site, Trial Master File, Regulatory Document, Internal Process, Database;

●Qualification Audits

●Quality System Audits

●Pharmacovigilance Audits

●Part 11 Validation Audits

●ECG; Radiology; Echo Vendor Audits

●IWRS Audits

●Medical Device Audits

●Auditor Trainer

●Standard Operating Procedure review and Gap Analysis

●Pharmacovigilance Auditing certification; Collaborative Initiative Training (CITI)

●Manager, Data Management

●Experience in all major therapeutic areas including Cardiovascular; Oncology; Neurology; Psychiatry; Infectious disease; Rheumatology; Immunology; Respiratory and Gastroenterology

●ICH E6 Good Clinical Practice

●ICH E2A; ICH E2A, ICH E2D;

EU Annex 11 Computerized Systems; Annex 15 Qualification and Validation and applicable Guidance

●United States Food and Drug Administration (FDA) 21 CFR Parts 11, 50, 54, 56, 312, 314, 801,803, 807, 812, 814, and 820

● (Canada) Health Canada

●Pharmacovigilance Safety Associate

●Medical Program Coordinator

●Computer System Validation (CSV)and User Acceptance Testing (UAT)

INTRODUCTION

A professional Quality Assurance consultant, working in pharmaceutical and biotechnology for over 18 years in the areas of Clinical R&D, Quality Assurance, Data Management and Pharmacovigilance; strong pharmaceutical industry experience in GCP Quality Assurance including GCP audits of, investigator site, pharmacovigilance, vendors, database, internal processes; labeling; batch records and packaging; lead teams in clinical research Data Management and Quality Assurance, managing large scale project simultaneously; proven track record managing; coaching and training of clinical research staff; new system implementations; extensive experience with system requirements gathering and documentation; experience in developing, managing and implementing controlled documents, including Standard Operating Procedures (SOPs) and Procedural Work Instruction Documentation, including performing Gap analysis; and facilitation of cross-functional teams to create/revise Standard Operating Procedures (SOPs) and Policies, producing high quality deliverables and developing and maintaining excellent client relationships; experience in the Pharmacovigilance (PV) area both in processing the safety information and auditing PV vendors and internal PV departments for clients; understanding of US and EU regulations. Responsible to ensure quality and compliance of clinical trials with applicable GCP

regulations, ICH GCP guidelines, SOPs, and current industry standards and best practices.

06/2024 – 02/2025 Estee Lauder Clinical Quality Assurance Consultant

Responsible for Clinical Study Report Review and conducting Supplier Audits part time.

12/2021 – 10/2023 Black Diamond Clinical Quality Assurance Genetic Therapy

Responsible for the development, maintenance and oversight of the GCP activities related to clinical trials; worked closely with Clinical Development and other supporting areas/development teams to help ensure continuous quality improvement activities; provided Quality oversight of internal and external clinical trial activities, related records, and processes to assure management in accordance with FDA regulations, ICH-GCP, SOPs and all other applicable regulations and assisted with other tasks necessary to achieve department and company goals.

06/2009 – 12/2021 Industry Consultant

Performed Investigator Site; Vendor CRO, Monitoring, Data Management, ECG; IWRS; Medical Device Services; labeling; packaging; batch record; Investigative Site, Pharmacovigilance Audits (internal, external); 21 CFR Part 11 Audits, System Audits including validation requirements; Trial Master File and Regulatory Document Audits according to GCP, GMP, applicable regulations, guidelines, company policies, SOPs and industry standards; prepared and issued audit reports, ensuring all observations are adequately addressed. Worked as in-house resource for Clinical Teams, providing Quality Oversight and Management; Performed Gap Analysis across Standard Operating Procedures; New Auditor Trainer. Performed Computer System Validation. ; Experience in all major therapeutic areas including oncology, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.

01/2009 – 07/2009 Orbis Clinical Clinical Quality Auditor Consultant

Performed Trial Master File, Internal Process (PV, Data Management); System and Investigative Site Audits according to GCP, applicable regulations, guidelines, company policies/SOPs and industry standards; prepared and issued audit reports and ensured all observations have been adequately addressed

07/2008 – 10/2008 ClinForce Clinical Quality Auditor Consultant

Performed Trial Master File and Database Audits; Prepared and issued audit reports; Authored Audit Plans and Standard Operating Procedures; Performed internal process audits

11/2005 – 05/2006 Wyeth Pharmaceutical Audit Manager I, GCP

Conducted Investigator Site, Vendor (CRO and Lab) and CSR Audits; Prepared and issued audit reports and reviewed all findings with Clinical Management and ensuring observations were adequately addressed; Performed Internal Process Audits; Reviewed and edited Standard Operating Procedures; Participated in internal and external training and process improvement; Maintained Audit tracking database; led and participated in the CAPA process

07/2005 – 11/2005 Kelly Scientific Drug Safety Specialist Consultant

Processed Adverse Event cases, assessed seriousness, defined labeling, entered Adverse Event data, authored narratives; encoded terms utilizing MedDRA and WHO; prepared follow up letters to health professionals; Consulted Medical Monitor regarding clarifications, ad hoc queries and approval of case; assisted with Ad hoc reports, submissions of periodic update and annual reports and product complaint management system updates.

12/2003 – 12/2004 Discovery Labs Sr. Quality Assurance Associate

Performed examination of trial related documents to determine whether data was collected, recorded, analyzed and reported accurately and according to GCP, applicable regulations, guidelines, comConducted

Conducted Investigative Site, Internal Process (Pharmacovigilance, Data Management and Statistics), CSR, Tables/Listing and Regulatory Submission Audits; Performed Quality Control of the clinical database and various trial related documents; Prepared and issued audit reports; Reviewed all findings with departmental management and ensured observations were adequately addressed; Authored and edited Standard Operating Procedures; Participated in internal and external training and process improvement and the CAPA process; Prepared the company for EU and FDA Inspections successfully

03/1996 – 12/2003 Merck & Co. Associate Manager Data Management

Clinical Trials Implementation Associate

Medical Program Coordinator

Managed clinical trials through review, computerization, cleaning and auditing of clinical data in compliance with standard operating procedures, client guidelines and regulatory agency guidelines; Supervised, mentored, trained and developed supporting staff; Authored and Maintained Data Handling/Review/Entry Guidelines; Performed Data Entry, Data Review and Discrepancy Resolution (including lab data); Authored Data Management Standard Operating Procedures; Performed SAE Reconciliation between Global Safety Database and Clinical Data Management Database; Responsible for Manual Encoding utilizing medDRA; Responsible for specification and validation of queries and edit checks; Assisted in defining, designing and validation of data collection tool, data queries, and reports; Performed and organized User Acceptance Testing on the data collection tools (Testing the software; maintenance and bug fixing); performed (CSV) Computer System Validation; Worked in coordination with IT, Clinical and Biometrics to gather requirements, design, develop implement and deploy the data capture tools (e.g., CRF, worksheets, and database software); Prepared Data Management presentations for use at the Investigator meetings

1992 – 1994

Allentown Osteopathic Hospital Registered Nurse, Telemetry Unit

1994 – 1996

Morristown Memorial Hospital Registered Nurse, Open Heart Step Down Unit

EDUCATION

1992

Lehigh Community College, Schnecksville, PA

Associates: Registered Nurse

ADDITIONAL TRAINING (not all inclusive)

●Telemetry

●MS Word, Excel, PowerPoint

●Oracle; EDMS; Argus; Aris G

●Adverse Event Reporting

●Safety Associate Training (Johnson and Johnson)

●Medical Program Coordinator Training (Merck)

●Electronic Data Capture training (Merck)

●Clinical Quality Assurance Training (internal, external)

●GCP (Good Clinical Practice) training

●PERI course Pediatric Clinical Trials

●Collaborative Initiative Training (CITI); Course In The Protection Of Human Subjects Curriculum

●Collaborative Initiative Training (CITI); GCP for Clinical Trials with Investigational Medical Devices

●Collaborative Initiative Training (CITI); GCP for Clinical Trials with Investigational Drugs and Medical Devices

●Pharmacovigilance and Drug Safety Certification/US/EU Course

●Pharmacovigilance Auditing Certification Course

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