SKILL:

• Windows 98/2000/XP, Microsoft Office 2000, 2003, 2007, 2010 (Word, PowerPoint, Access, Excel Outlook)
• Apple Mac OS X Versions 10.0 - 10.8, Lotus Notes, MS Project, Internet Research and Applications, NetDocs
• ISIPublisher, ISIToolBox, CRFTrack, CRFScan, Adobe Acrobat, FrontPage 2000, FoxPro, IMPACT, InputAccel
• DocuBridge, Documentum, AESOP, MIDAS TMF, Oracle Clinical (4.0), Clintrial, MedDRA, CuteFTP, CELTRAK, CELECT, WebEDI (CREDI, REDI, TEDI), Fisher Web Order, GCP/GMP

PROFESSIONAL EXPERIENCE:

Confidential, East Hanover, NJ

Clinical Supply QA - US CPO - TRD-QA Release Manager

Responsibilities:

• Responsible for the quality review, approval and release of Investigational Medicinal Products (IMPs) to individual trial sites in the US & Puerto Rico.
• Liaise with Clinical (all therapeutic areas), Drug Regulatory Affairs (DRA), Drug Supply Management (DSM) and Distribution Vendors, IVRS/IRT Vendors and Contract Research Organizations (CROs) to reconcile site & drug information in order to ensure accuracy and efficiency in the workflow process for drug shipments.
• Assist with project to develop new working processes to be implemented into an updated SOP, which would adhere to new QA requirements under the US-CPO.
• Ensure the accuracy of drug requests by verifying that the information therein (investigator name, address, protocol) matches the FDA Form 1572. This includes any amendments that have taken place prior to release of IMP.
• Verify the submission process has been completed in accordance with 21 CFR Part 312. Record serial number for submission in QA database.
• Confirm that 1571 application has been submitted to the FDA for new INDs.
• Perform quality check on the following to ensure local regulatory requirements regarding initiation of a study in the country and approval of clinical trial site have been met: Protocol, FDA Form 1572, IRB Approval, PI CV, Medical License, Verification of Documents Receipt (VDR), Ready to Initiate Site (RIS) Form, FDA Debarment List.
• Assist with the reconciliation of monthly metrics in the QA database in regards to all drug shipments and especially initial shipments.
• Ensure GMP & GCP compliance or patient safety issues are escalated through the proper channels.
• Ensure all electronic records & signatures are in compliance with GMP & GCP, Novartis SOPs and 21 CFR Part 11 requirements.
• Lead Documentation Management Specialist on one of Celgene’s largest on-going trials (159 sites 11 countries). Liaise with study team members in these countries to coordinate the consolidation and reconciliation of the TMFs for this study.
• Responsible for review, reconciliation and processing of transmittal form packages containing clinical trial documentation.
• Perform all functions related to CELECT (eTMF) including scanning, image QC, index and index QC
• Prepare CRFs/DCFs for review (Clinical Operations & Medical Writing) and regulatory submission.
• Hyperlink and bookmark CSRs in preparation for publishing and submission.
• Identified companies that provide business continuity and disaster recovery solutions for the department; potential company-wide implementation.
• Perform all functions related to the management of TMF documents: document & transmittal receipt, scanning, filing, QC, metrics, tracking of Safety Reports and IBs.

Confidential, NJ

US Clinical Affairs - Clinical Document Specialist

Responsibilities:

• Responsible for the coordinating, scanning and QC of all clinical and regulatory documentation in preparation for NDA submission.
• Liaised with all members of the clinical study team, CROs and site staff in order to reconcile the trial master files (TMFs).
• Assisted with the editing and organizing of the appendices for the clinical study report (CSR)
• Responsible for the QC and archival of CRFs and DCFs retrieved from vendors.

Confidential, NJ

US Medical Affairs - Clinical Archive Specialist

Responsibilities:

• Acted as Assistant Project Coordinator for potential company-wide global implementation of an electronic Clinical Trial Document Repository (eCTDR) to assure documents are in compliance with 21 CFR Part 11.
• Assisted with development of project requirements, which included: document management, workflow & process management, clinical trail (project) management, submission management and budget & approval phases.
• Created a pilot of the CTDR in the eRoom using studies that were volunteered by the CTMs under the current SOP guidelines.
• Responsible for overall support of the Trial Master File (TMF) Room including: Initial setup of TMF filing structures for new trials, mapping/tracking of studies housed in the TMF room, scanning, hyper-linking and bookmarking of study files within CTMS, QC of study documents and the archival of closed and/or inactive studies.
• Liaised with study sites, legal and records management to coordinate clinical archive projects.
• Directly assist with the organization of Investigator Meetings and Data Monitoring Committee Meetings including compilation of materials, meeting presentations, and scheduling activities.

Confidential, NJ

Senior Level III Technical Document Operation Specialist

Responsibilities:

• Assist in the management of records related to the company’s ongoing Phase I, II and III clinical programs to assure that all documentation is in compliance with current regulations, cGCP/ICH and SOP requirements.
• Schedule and participate in Study Team meetings and distribute meeting minutes in TMF.
• Prepared highly complex technical, medical, and scientific documentation for regulatory submissions for all pharmaceutical and biological products in MRL development.
• Managed documents in CTMS through all phases of workflow: review, approval and publishing.
• Modified documentation to accommodate specific regulatory agency requirements and electronic publishing specifications in DocuBridge, NetDocs and TMF.
• Review and publish to completion clinical study reports used in submissions to the FDA.
• Processed IRB Approvals, Protocols & Amendments, Clinical Study Reports (CSRs), Worldwide Marketing Application (WMA) sub-sections, Expert Reports, Data Analysis Plans, Periodic Safety Update Reports (PSURs), and FDA Advisory Committee Background Packages using system templates for authoring community.

Confidential, Whippany, NJ

Document Specialist

Responsibilities:

• Processed highly sensitive documents for various pharmaceutical companies in preparation for NDA, IND and BLA submission to the FDA (CBER/CDER)
• Responsible for handling and preparation of clinical and controlled documents, which included Case Report Forms (CRFs), Data Clarification Forms (DCFs), Lab Reports and other patient data.
• Processed Study Reports to comply with regulations of electronic submissions.
• Scanned study files into EDMS (Electronic Document Management System)
• Created both Image and Text-Based Hyperlinks and Bookmarks for NDA IND and BLA submission
• Traveled to client’s headquarters for on-site submission process. (Canada)
• Performed Quality Assurance for preparation, processing and final publishing of electronic submissions according to the SOPs and GCP guidelines.
• Accountable and responsible for the development and maintenance of customer data on system.
• Supported staff to properly utilize existing and new procedures.
• Managed all monthly customer data on Microsoft Excel Spreadsheet.
• Coordinated key files for the department heads.
• Generated, revised, controlled and issued documents including: Device History Records, Quality Control Test Records, Equipment Logs, Lab Notebooks
• Removed obsolete/invalid Standard Operating Procedures (SOPS)
• Assisted with major projects for year-end documentation
• Worked with NetDocs software and eLearning to further and development

Confidential, NJ

Engineering Assistant/Machine Operator

Responsibilities:

• Responsible for assisting the engineers with key projects and quality inspection.
• Managed and recorded all vendor data on Microsoft Excel Spreadsheet.
• Operated various machines: Plastic extrusion, silkscreen, labeling and hot stamp.
• Communicate and coordinate specific assignments between Business units and vendors.
• Assisted with the distribution of corporate correspondence internal and external.
• Assisted Director with administrative functions when needed.