Elmhurst, NY 11373
Cell Phone: 407-***-****
A highly motivated professional with eleven years of Pharmaceutical Industry experience. Seven years of experience with documentum, clinical trial management database systems and three years experience with electronic document management system. Excellent experience collaborating with teams across multiple platforms thorough knowledge of all Microsoft programs, as well as proficiency in organizational skills, written skills and communication skills. Seeking a position that will enable me to consolidate my professional experience, expand my knowledge and provide opportunities for growth.
●Strong experience with ISI toolbox and adobe acrobat professional
●Project Coordination proficiency
●Trial Master File Management - Proficient in Electronic Trial Master File Management through Clinical eDoc (D2) File Management System, Accelerate Electronic File Management System and Paper Trial Master File Management
●Proficient in Clinical Trial Database System for development, testing, production and implementation
●Proficiency in e-Room and Documentum database systems
●Quality e-Doc proficiency
●Data Entry Operator - Type 60 wpm
●Clinical Study Lead to various clinical trials
●Speak and write Spanish fluently
●Strong experience with scanning and uploading of Paper Trial Master File documents.
●Strong experience with Trial Master File Quality Review and Reconciliation paper and electronic file
●Experience with Trial Master File Veeva Vault Electronic File Management System
●Experience with SharePoint and Accelerate Trial Master Electronic File Management System
●Proficient in Microsoft Word, Microsoft Excel, Microsoft PowerPoint, and Microsoft Outlook
Merck – North Wales, PA
Technical Documentation Operations Specialist
09/2016 – 11/2016
●Performed system administration activities required to activate/initiate/closeout study sites or studies in Phase II to V clinical trials and manage the input of data into specific applications
●Performed manual data entry in: CTMS, TMF, CRF Imaging and various departmental databases
●Ensured consistent receipt, analysis, classification, registration and disposition/filing/retrieval of hardcopy and electronic clinical trial essential documents and other clinical trial related documents to allow for their consistent tracking, inspection and security
●Screened and sorted incoming paper and electronic mail. Date and time stamp cover sheet of incoming documents. Determined appropriate routing. Prepared outgoing mail and distribute
●Coordinated communication regarding progress and completion of study documentation, package creation and data entry activities to the various functional areas as appropriate
●Configured, created, monitored, and updated Regulatory Packages
●Monitored and tracked appropriate documentation to meet contracted and agreed upon SR timelines
●Coordinated study-specific clinical templates needed for tracking purposes located in Administrative Binders that are distributed to the study sites
●Maintained weekly document processing metrics, errors, returns, and delays for department excel spreadsheet
Covance Clinical Development Services - Princeton, NJ 01/2016 - 07/2016
●Reconciliation of Paper Trial Master File and Electronic Trial Master File
●Ensured all Trial Master File documents are audit check ready
●Scanned and uploaded of Data Management documents into electronic document management system
●Ensured the readiness, delivery, and receipt of Paper Trial Master File documentation for archival
●Processed study document requests from cross-functional team members to ensure that all urgent requests and inquiries are being handled in a timely manner for all assigned studies.
Highgate Hotels – Paradise Stream Resort– Mt. Pocono, PA 08/2015 – 11/2015
●Responsible for planning, organizing, and developing of the overall operation of the housekeeping department in accordance with federal, state, and local standards and guidelines along with assuring the highest degree of quality guest care is maintained at all times.
●Responsible for staffing, scheduling, training and developing hourly staff.
●Purchased, re-ordered and maintained housekeeping supplies and inventory.
●Maintained the housekeeping budget, providing billing summaries and expenses for all pre and post events.
●Conducted inspections of all rooms, concourses, clubs, seating areas and public areas prior to every event including guests’ arrival, stay, and departure.
●Responsible for customer service conflict resolution.
Sanofi Pasteur - Swiftwater, PA
02/2010 - 11/2013
Clinical Documentation Coordinator
●Set-up, maintained, and archived the Trial Master File to the required standards and supported the electronic document management system administration activities from start up until study closeout.
●Worked with clinical team members to ensure that Clinical Department TMFs were complete on an ongoing basis, and at the end of the trial.
●Provided training to Sanofi Pasteur staff members on the requirements of the Clinical Department Trial Master File and relevant Standard Operating Procedures.
●Performed administrative and technical tasks for the Electronic Document Management System in support of the Clinical Documentation Manager.
●Managed Global File List and managed pick-list updates as functional administrator within the Electronic Document Management System.
●Provided functional support to users of the Electronic Document Management Database System.
●Managed Access Requests for creating new user accounts with the Brainshark system.
●Responsible for communicating access approvals of users to the Electronic Document Management Database System through email response.
●Reviewed and validated DISC request upon receipt.
●Created and maintained Clinical Trial ID Card for each clinical study assigned in Clinical e-Doc (D2).
●Prepared Trial Master File documents for audits and inspections.
●Worked regularly with all levels of management and employees internally and externally.
●Assisted with development of solutions to improve new and existing processes and computer operations.
Sanofi Pasteur - Swiftwater, PA
11/2006 - 02/2010
Clinical Data Coordinator
●Participated in the data collection and management of moderately to highly complex clinical trials. Coordinated data processes related to more than one clinical trial.
●Participated in the testing and validation of study specific data.
●Assisted in the creation, archiving and distribution of project specific documentation.
●Tracked queries in the query management system and resolved queries working alongside Clinical Data Managers and study site personnel as appropriate to study specific work processes.
●Reviewed safety data through the validation of data listings.
●Validated data entry screens and edits checks in the Clinical Data Management System.
●Performed quality control of scanned case report form images including hyper linking of pages scanned including source documentation for the preparation of clinical study submissions.
●Performed quality control of clinical study reports and other quality documents as required with the use of established processes, standards and guidelines for audit inspections and submission readiness.
●Imported case report forms via Documentum-based Electronic Document Management System.
Sanofi Pasteur - Swiftwater, PA
08/2003 - 10/2006
Clinical Data Technician
●Data entry operator lead to specific Clinical Trials.
●Created and maintained excel log sheets for tracking of Case Report Forms.
●Entered mock data into Clinical Trial System.
●Entered Case Report Form pages in the production instance and ran verification reports using Clinical system.
●Performed manual QC Audits.
●Performed general administrative duties.
Manpower/Aventis Pasteur - Swiftwater, PA
09/2002 - 07/2003
Data Entry Operator
●Scanned 2000+ GxP documents in Documentum 4.1i using Adobe Acrobat.
●Added and revised properties in Documentum to ensure correct information entered the system.
●Made photocopies for official and special issue requests in the Records and Systems Department.
●Manual auditing and filing of Data Tables and study reports for the Quality Control Department.
●Entered data for clinical studies following specific data entry protocol guidelines.
●Sorted and filed case report forms, manual QC auditing and notation of protocol discrepancies on specific trials.
●Scanned and indexed case report forms for various clinical trials using Feith Document Database in the Clinical Data Management Department.
Associates Degree in Web Programming
Rasmussen College – Online, Expected Graduation March 2017
Vocational/Technical Certificate in Computer Training
Monroe County Career and Technical Institute Bartonsville, PA, August 2002
Executive Business Diploma in Word Processing
Drake Business School New York, NY, June 1994