Over 10 years of experience as an Document Specialist in the Pharmaceutical industry. Strong organizational abilities combined with excellent interpersonal, communication, and leadership skills that allow me to work effectively with diverse populations at all levels.
Scheduling Microsoft Office
Flexible Detail-oriented Microsoft Office
Professional and mature
Multitasking and prioritization
File and data retrieval systems
Technical Document Operations Specialist (TDOS)12/2016 to CurrentMerck & Co IncWest Point, PA
system administration activities required to activate/initiate/closeout study
studies in Phase I to IV clinical trials and
manage the input of data into specific applications
Perform manual data entry in: CTMS, TMF, CRF Imaging and various
Ensure 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
Coordinate communications regarding progress and completion
of study documentation,
package creation and data entry activities to
the various functional areas as appropriate
Maintain weekly document processing
metrics/errors/returns/delays for department
Sort, prepare, process and file hardcopy mail.
Oversight of the Initiation Mailbox to ensure documents are
processed in accordance with the
TMF Master List and within agreed upon SR
Facilitate the archiving of outsourced trial documents
of inventory spreadsheets and DVDs/CDs for outsourced trials
Up with CRO as needed throughout the process to ensure documents are
archived appropriately and in a timely fashion
Recall study documentation from archive as needed, review
contents as instructed, then return
study documentation to archive in a timely
Address EDM/Clinical/CRA requests
Ongoing RCAM>TMF Reconciliation
Audit and Inspection support, as needed
Trial File Binders
template preparation prior to clinical team review
specific binder template negotiation with clinical team
o Assist with binder creation per site
Medical Records Technician06/2014 to 12/2016Omnicare PharmacyKing of Prussia, PA
Maintains the pharmacy generated medical record component of customer charts at the centers serviced by the pharmacy.
Accurate maintenance of all facility forms and reporting information Print monthly medical records package which includes physician orders, medication sheets, treatment sheets, flow records, etc.
for all facilities.
Reviews and edits monthly physicians order forms and telephone orders returned to the pharmacy, to input recap notations, non-medication order changes and other information provided relative to medical records.
Records Administrator II02/2003 to 12/2010Wyeth PharmaceuticalsCollegeville, PA
Performed quality control of imaging/scanning and indexing functions, updated and maintained Corporate electronic records archival systems and databases, and acted as liaison for all records activities and audits of electronic systems to ensure compliance with all rules and regulations.
Validation of Software System Implementation for Corporate Records Management.
Provided assistance to the Director of Corporate Records Management.
Handled highly confidential and proprietary information.
Managed and maintained schedules, calendars, meetings, and organized travel arrangements, corporate agendas and itineraries, and.
Developed and facilitated Power Point presentations for related on- and off-site meetings.
Created Corporate Records Management Website within Web Builder.
Assisted with the coordination of monthly Facility Audit program by keeping an accurate account of all common files in Great Valley and Collegeville locations and by reporting percentages of utilized file space.
Maintained up-to-date service issue records for follow-up and resolution at monthly meetings.
Maintained database of all boxes due for destruction and kept reports on all current destruction documents.
Created memo authorization sheets to send out for approval on boxes currently due for destruction.
Demonstrated leadership by acting as a mentor for summer interns Provided guidance and education regarding the Records Management Program.
Placed orders with Iron Mountain, offsite storage provider, on a daily basis and worked to resolve any outstanding issues that would arise during delivery/storage.
Responsible for control of data entry in the filetracker database.
Records Administrator09/2001 to 02/2003Wyeth PharmaceuticalsCollegeville, PA
Established guidelines and procedures to process regulatory records and assured the completeness of hardcopy archival collection managed by the GRR.
Verified the quality of indexing for regulatory records stored in the official electronic management system.
Independently performed all rotating task assignments to complete all steps.
Processed regulatory records.
Assisted in retrieving, indexing, burning CDs, and organizing documents for WWRA, Legal, or Global Brand Development requests.
Performed general administrative duties, clerical, and receptionist tasks, in support of department's functions.
High School Diploma: General1998Methacton High SchoolFair View, PAGeneral
ARMA International member in 2008-2010
administrative, Brand Development, charts, clerical, Creative Problem Solving, Critical
Thinking, Client Relations, Customer Service, Data Collection, Data Entry, databases, database, delivery, Documentation, Email, Executive Management, Filing, forms, imaging, indexing, leadership, Legal, Letters, Director, meetings, mentor, Microsoft Excel, Microsoft
Office Suite, Microsoft Outlook, Microsoft PowerPoint, Power Point, Microsoft Word, Needs Assessment, Internet Research, Organizational Skills, organizing, policies, presentations, quality, quality control, receptionist, reporting, Research, scanning, Scheduling, Spreadsheets, telephone, Telephone Skills, Time Management, Travel
Arrangements, travel arrangements, Typing, Validation, Vendor Management, Website