SUMMARY

• A Multi - Skilled Professional with 7 years of experience in Data Management and Quality Assurance within a Clinical and Regulatory Environment
• Applies Very Good Quality and Accuracy to Work
• Well Versed and Adaptive in Applying Quality Assurance Principals
• Experienced in Administrative Audits, Quality Control and Strong Application with FDA Regulations
• Fast Learner in Working with Computer Systems:
• Experienced in Such Programs as Oracle Argus 7.0.2, Electronic Data Capture Systems, Seibel Customer Relationship Management (CRM), (D2) Documentum, Sage X3 Enterprise Resource Planning (ERP),

TECHNICAL SKILLS

• Oracle Argus 7.0.2
• Electronic Data Capture Systems
• Seibel Customer Relationship Management (CRM)
• Sage X3 Enterprise Resource Planning (ERP)
• Expedata
• SPSS
• Google Docs
• Microsoft Word
• Outlook
• Excel
• PowerPoint
• Microsoft Access
• Microsoft Project

PROFESSIONAL EXPERIENCE

Confidential, Bridgewater, NJ

Data Management Analyst

Responsibilities:

• Performs Data Clean-Up, Data Entry, and Reconciliation of Clinical Trial Phases me, II, III and
• Post Market Trial in Electronic Data Capture Programs, Seibel and Oracle Argus 7.0.2
• Analyzes and Resolves Errors dat Populate in Edit Check Reports and Reconciliation Reports.
• Performs Registration and Case Intake of Phase IV, Post Market Cases, Using teh Seibel Customer Relationship Management (CRM) Application and teh D2 Documentum Enterprise Document Management (EMC)
• Manages and Oversees Time Sensitive Adverse Event Reports and Medical Information from Patient Support Programs, Clinical Trials and Market Research Vendors.
• Performs Data Mining on FDA AER Quarterly Report.
• Registers Post-Market Adverse Event Reports Received from Patient Support Programs, Clinical Trial Cases, Market Research, Insurance and Specialty Pharmacy
• Assists teh Triage Manager with Tracking, Prioritization and Distribution of Adverse Events and Product Technical Complaint (PTC) Investigation Reports
• Applies and Adheres to FDA Regulations: ICH-CGP (International Conference of Harmonization, Good Clinical Practices), 21 CFR 312, 21 CFR 314, Corrective Action Preventative Action (CAPA), SOP Guidelines and Company Policies and Procedures

Confidential, Edison, NJ

Documentation Specialist / Contractor

Responsibilities:

• Created, Maintained, Catalogued and Retrieved Chemical Specification Sheets, Certificate of Analysis (CoAs), Safety Data Sheets (SDS) and Lab Analysis Sheets
• Updated Lab Analysis Sheets and Specification Sheets up to teh Food Chemical Codex (FCC) and United States Pharmacopeia -National Formulary (USP-NF) Standards of Testing
• Entered and Researched Inventory on ChemPax Software System
• Trained on Sage X3 Enterprise Resource Planning (ERP)
• Responsible for Updating and Tracking Vendor current Good Manufacture Practices (cGMP) Questionnaires to Comply with Federal Regulations and Vendor Qualifications
• Adhered to current Good Manufacturing Practices(cGMP), ISO 9000 Quality Management Systems, Occupational Safety and Health Administration (OSHA), Corrective Action Preventative Action (CAPA), and Good Documentation Practices (GDocP)

Confidential, New York, NY

Drug Safety Assistant /Contractor

Responsibilities:

• Performed Clinical Data Entry Using Oracle Argus Version 7.0.2
• Trained in STAR (Safety Tracking and Reporting) Software Version 1.20
• Researched Safety Management Plans (SMP), Investigator Brochures and Protocols to Fill in Study Checklists
• Entered and Activated Studies on STAR Version 1.20 (Safety Tracking and Reporting) for Clinical Trial and Post-Market Cases
• Registered TEMPPrincipal Investigator, Site, Institutional Review Board (IRB) and Ethics Committee Information from teh CTMS (Clinical Trial Management System)
• Contacted and Corresponded with Global DSPMs (Drug Safety Project Managers) for Study Updates
• Adhered to Good Clinical Practices (ICH- GCP), ICH e6, Corrective Action, Preventative Action (CAPA)

Confidential

Quality Assurance Document Control Specialist/Contractor

Responsibilities:

• Assisted with cGMP & CAPA Administrative Audit
• Reviewed, Investigated & Rectified Corrective Action/Preventative Action (CAPA) Deviations for Medical Device
• Maintained and Updated Records and Databases in teh Mastercontrol & Trackwise
• Updated FDA Inspection Logs, Validation Documents and Batch Records.
• Entered Data and Performed QC Reviews of Validation Documents in MS Excel
• Applied & Adhered to current Good Manufacturing Practices (GMP), Corrective Action Preventative Action (CAPA), and Quality System Management Principal

Confidential, Princeton Junction, NJ

Drug Safety Data Management Specialist /Contractor

Responsibilities:

• Follow-up Letter Processing for Adverse Events on Oracle Argus
• Generated Follow-up Letters from Activities Tab in Argus and Uploaded in Additional Tab
• Monitored and Managed 1st and 2nd Letters to Consumers and Healthcare Professionals
• Updated Drug Safety Unit Mailbox
• Adhered to Pfizer’s Policies and Procedures, SOP Guidelines and International Conference of Harmonization-Good Clinical Practices (ICH-GCP)

Confidential, Cranford, NJ

Data Coordinator/ Quality Control Reviewer

Responsibilities:

• Assisted with Data Clean-Up and Data Management in Phases II and III of a Multi-Centered, Placebo Controlled Clinical Study
• Researched and Reconciled Data for MS Excel programmed Edit Check Reports
• Verified and Committed Clinical eCRFs (electronic Case Report Forms) using Expedata
• Updated Adverse Events, Concomitant Medication, Self-Evident Corrections, and Documentation in MS Excel and Docmall
• Performed Quality Control Reviews of Various Clinical Research Studies
• Adhered to Good Clinical Practices (GCP), Good Documentation Practices (GDocP), Good Manufacturing Practices (GMP), and company Standard Operating Procedures (SOPs

Confidential, Woodbridge, NJ

General Office Administrator/ Project Assistant

Responsibilities:

• Assisted with Administrative SOP Audit Project in Preparation for Government Inspection
• Tracked, Audited and Updated SOPs for 6 Departments: Histology, Cytology, Accessioning, Transcription, Client Services and Logistics; Ensured dat Department Signatures, SOPs were Compliant
• Worked with HR Personnel Files of Laboratory Employees to Create Audit Criteria Excel File
• Created, Maintained, Catalogued and Retrieved Laboratory Documents/Templates
• Data Entry for QA Case Reviews/ MS Excel Related Projects
• Maintained Company Records, Data and Files as an Inventoried List in Microsoft Word