Data Entry Manager

Shana Richardson

** ***** ******, **** ******, NJ 07018 (Phone) 973-***-**** ********@*****.***

Career Summary

A professional with 17 years of experience in the pharmaceutical industry. Proven ability to function within a team and as an independent contributor. Self-motivated with excellent organizational skills, demonstrated customer focus and strong interpersonal skills.

Professional Experience:

Cotton Funeral Service, Newark, NJ

Receptionist (December 2015 to Present)

Answer and direct calls to the appropriate Funeral director/Manager

Receive incoming telephone calls and assist callers with any questions or comments

Greeted and receive client families and/or other persons entering the office for information and assistance

Scanned, faxed and prepared Prayer Cards for families

Perform a variety of tasks during funerals to assist funeral directors and to ensure that services run smoothly and as planned

Opens and sorts mail

St. Matthew AME Church, Orange, NJ

Security/Office Helper (November 2014-November 2015)

Direct members and non-members to their appropriate activity/rehearsal

Prepared bulletins for Sunday’s worship service

Worked sound booth for choirs to have rehearsal

Made copies

Answered phones and took messages

Made rounds on the outside grounds as well as the inside

Closed and locked up church

Regeneron Pharmaceutical, Tarrytown, NY

Clinical Document Associate (Contract) (CDMA) March 2014 May 2014

Renamed, filed electronic documents in eTMF system, ICF’s 1572’s Financial Disclosure Forms, CLIA Amendments, Deviation, IB’s CRF’s, Protocols etc.

Tracked and performed quality control of paper documents into EDC

Prepared and transitioned study documents to long-term archiving facility

Retrieved study documents from long term facilities when requested by teams and management

Novartis Pharmaceutical, East Hanover, NJ

IT Applications/SharePoint 2010 Support Associate (Contract) (Oncology) September 2012 May 2012

Worked closely with IT developers to configure and administer SharePoint Unit Sites

Enforce standards when implementing sites and sub-sites, along with other features of the environment

Manage intranet sites built on SharePoint 2010 and support the migration of SharePoint 2007 data

Worked with MA & CD teams to organize trial documents per defined folder structures in SharePoint 2010

Administered and maintained sites and sub-sites, site and system security along with structure and content

Created folder structures as required and migrated documents on shared drive into SharePoint 2010

Reconciliation of documentation and ensured that documents were available for every trial

Support system to Clinical Trial Teams in navigation through SharePoint

Delegated access on different levels, roles, responsibilities within SharePoint 2010

Merck Pharmaceutical, Whitehouse Station, NJ

Compliance Coordinator (Contract) (Global Health Outcomes) January 2012 to September 2012

Perform denied parties screenings of individuals list in the FCPA and the Compliance checks ensuring consistency and compliance

Provided documentation of the results of the screenings to GMAx manager

Review, identify, update all Due Diligence red flags and denied parties screening matches as per GMAx manager

Ensured FCPA Due Diligence was renewed in accordance with compliance requirements

Queried, reconciled, updated and ensure compliance with policies and procedures in OIG, EPLS, and OFAC results in SAP Database to the manager

Provide vendors with copy of the appropriate SOP’s and the FCPA training materials

Assisted senior staff in supporting activities, related to reporting requirements of observational studies

Maintained databases of observational studies to ensure compliance with reporting requirements

Liaison between study research teams in Clinical Trials

Identified, requested and ensured delivery of FCPA issues

Johnson & Johnson Pharmaceutical Research & Development, Raritan, NJ

eTMF Documentation Associate/Administrative Assistant (Contract) November 2010-April 2011

Supported the Investigator Document Assistant (IDA)

Filing essential documents and maintenance of the TMF

Retrieved study documents from long term facilities when requested

Faxed, scanned documents into electronic format prior to importing into TMF, ICF’s, 1572’s, Financial Disclosure Forms, CLIA, Amendments, Deviations, IB’s etc.

Excel tracker sheet communication between managers

Performed visual quality checks of e-documents prior to import to confirm image clarity and readability

At the end of studies review study files for organization, reconciliation for accuracy, completeness

Assisted with the maintenance of complex study files per SOP’s

Administrative duties (i.e. photocopying of document, paper file setup, etc.)

Accenture, Florham Park, NJ

Scanner/Indexer (Contract) January 2008-July 2009

Received and QC’d CRF’s for completeness

Scheduled video conferences

Created instruction manuals for CRF scanning/indexing process

Collaborated closely with international customer/to resolve DE issues

Trained new hires on the scanning/indexing process

Schering-Plough Kenilworth, NJ

Clinical Trial Associate/CRF Indexer (Contract) (Oncology)

Ensured receipt of all patient-specific case report forms (CRF’s)

Audit source documents for quality and legibility prior to submission to Clinical Document Warehouse

Determined if any documents required translation; forwarded documents to appropriate parties

Reviewed source documents for violations of HIPAA guidelines

Executed corrections to source documents according to GCP guidelines

ClinPro Incorporated, Bound Brook, NJ (Contract) August 2006-May 2007

Data Entry III, Senior Data Entry (Consultant) (Contract)

Performed second key entry and data cleanup

Validated database information for clinical drug studies

Created user instructions documents

Generated and resolved edit checks and manual queries

Roche Laboratories, Nutley, NJ

Clinical Data Entry Operator (Contract) (Consultant)

Assisted with updating and verifying clinical data, resolving data discrepancies and other related issues

Reviewed and updated data in Oracle Clinical Database and identified data entry problems and errors

Performed data entry screen testing

Ingenix Pharmaceutical Services, Basking Ridge, NJ Clinical Data Associate October 2000-January 2005

April 2001-January 2005

Reconciled and reviewed first and second pass data entry

Setup patient and investigator information

Uploaded documents within EDC (Electronic Data Capture)

Interacted with clinical data coordinators to negotiate Project Timelines

Reviewed data listings for verification

UAT Testing

Reviewed discrepancy database, generated query of DCF’s and audited various studies

Assisted with filing of case report forms and utilized Oracle Clinical and SAS

Clinical Data Entry Operator October 2000-January 2005

Performed first and second pass entry from case report forms (CRF’s)

Reviewed clinical data of assigned studies for consistency & accuracy; reconciled between clinical ranges

Audited various studies and assisted filing of case report forms (CRF’s)

Technical Skills:

Microsoft Office Suite, Word, Excel, PowerPoint, SharePoint 2010, eTMF, Clinplus 2.1, 3.2, Oracle Clinical 3.1, 3.2, 4.0, SAS

Education:

Colorado Technical University, Colorado Springs, Colorado (Online)

Pursuing BSBAE in Project Management 8.0

Other Licensures:

SORA License, Copco Detective Agency, Basic CPR Training September 2014

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