Customer Service Management
Resume:
SAMIR RANA *** Gregory Avenue, B* ( Passaic, NJ **055 ( *******@*****.***
www.linkedin.com/in/samirrana
DOCUMENT SPECIALIST ( DATA COORDINATOR ( RECORDS MANAGER
Talented technology professional with more than 11 years of experience in
document and data management, data processing, information and records
administration, and project management for companies in the pharmaceutical
industry. Detail- and process-focused, with a track record of contributing
to the successful completion of many projects with aggressive timeframes.
Proficient in document publishing tools and electronic management systems.
Knowledgeable in regulatory guidelines. Collaborate and effectively balance
the needs of the project, team members, vendors, and others. Microsoft
Certified Professional (MCP).
Core competencies include:
Project Administration ( Data Collection & Analysis ( Document Publishing
Electronic Records Management ( Policies & Procedures ( Quality Control (
Troubleshooting
Professional Experience & Achievements
Overview: Work through staffing agencies on various projects for companies
including GlaxoSmithKline, Eisai, Baxter, Celgene, Johnson &Johnson, and
Pfizer.
GLAXOSMITHKLINE, Parsippany, NJ February 2013(October 2013
Information and Record Specialist
Worked directly with the Chemistry Manufacture Control (CMC) Director to
build Health Authority QA database from proprietary information to meet the
requirements of Electronic Common Technical Document (eCTD) guidelines.
Assisted in finalizing CMC templates regarding formatting, hyperlink, and
consistency between the various sections. Created detail instructional
document for how to navigate Health Authority QA database.
EISAI INC, Woodcliff Lake, NJ June 2009(June 2012
R&D Documentation Management/Scanning
Built and maintained storage of phase I, phase II, and phase III trial
master files (TMF), including serious adverse events and case report forms
(CRF) documentation for clinical trials. Assisted with management of off-
site records storage. Maintained a high volume of TMFs; copied protocols,
clinical study reports, and CRFs as needed. Conducted shipping and
retrieving of TMFs, CRFs, and CSRs and maintained up to date electronic
storage logs. Scanned and imported TMFs and CRFs into Documentum and other
eTMF systems.
. Created detailed instructional document/process map for processing CRFs.
. Worked with clinical site profile database, importing and updating data
and extracting information from spreadsheets for CSR components.
. Archived 1058+ boxes of study records during file transfer/centralization
from one location to another.
. Completed archival of all study sites and files to meet established
deadline.
BAXTER, New Providence, NJ April 2009
Clinical Documentation Specialist
Managed recognition, sorting, and organization of clinical documents for
the clinical library.
CELGENE CORPORATION, Summit, NJ January 2008(December 2008
Documentation Specialist
Managed document support of Good Laboratory Practice (GLP) and non-GLP
studies for non-clinical early drug development (exploratory toxicology,
pharmacology, and drug metabolism pharmacokinetics). Helped create summary
and study report submissions. Coordinated with contract research
organizations and internal labs, communicating changes/status of
submissions. Tracked reports through review cycle and maintained internal
document tracking and management systems. Ensured that documents followed
FDA and International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceutical for Human Use ICH guidelines. Provided
support to regulatory operations groups.
. Created spreadsheets that simplified and expedited interpretation of
complex data for toxicity studies, and shortened project duration time
50%.
. Completed 47 non-clinical study reports in 1 year.
SAMIR RANA *******@*****.*** 201-***-**** Page 2
JOHNSON & JOHNSON, Raritan, NJ April 2007(December 2007
Business Services Associate
Compiled clinical trial documentation, including protocols and consent
forms for the Virtual Document, Appendix 1. Created and migrated virtual
documents and complex records into GRIPS Documentum database. Managed
transfer of documentation between GRIPS and external contractors. Obtained
all supporting documentation for the document and journal references.
Coordinated with appropriate clinical trial associate, data management
personnel, document specialist, and regulatory department.
. Used ISI Toolbox/Validation to prepare files for e-submission readiness.
. Awarded Certificate of Appreciation from the development team for
effectively collecting and inputting references into the appropriate
databases.
PFIZER INC., Morris Plains, NJ June 2006(April 2007
Medical Data Coordinator
Managed recognition, sorting, and organization of NDA, IND, MAA, CMC
section, consent decrees, and other files in regulatory operation group.
Coordinated archiving and storage processes for documents and clinical and
regulatory records. Maintained patient and research RADARS Documentum
database.
INDEPENDENT CONTRACTOR February 2003(November 2005
Placed on projects through agencies to consult with companies, providing
technical expertise in the areas of hardware/software technology issues and
data processing. Gathered client requirements. Translated technical
language/data for non-technical users. Assignments included:
Honeywell Corporation: Supported more than 1,400 end users in various
desktop and technical applications and operations, including memory
upgrades, printer configuration, hardware repairs, and security checks.
C3I Inc.: Configured more than 200 laptop computers according to project
specifications, including data migration for top pharmaceutical companies.
Recognized by project lead for excellence in error free work.
Cingular Wireless, Inc.: Analyzed and resolved technical issues in the data
and customer service centers.
Freelance Computer Technician: Troubleshot hardware/software problems,
performed system upgrades, and set up networks.
Previous Experience
UBS/PAINE WEBBER, Secaucus, NJ, Stock Option Plan Administrator (August
2000(December 2003)
Started as a temporary employee and subsequently hired to handle reporting,
database balancing, and account management for corporate clients. Imported
account and transaction files into UBS platforms per defined procedures.
Ran assigned monthly reports to assist with the roll-forward process.
Provided comprehensive support to internal clients, including customer
service, operations, client relationship managers, implementation team, and
financial advisors.
NIELSEN BAINBRIDGE, Paramus, NJ, Computer Operator Helpdesk (May
1999(January 2000)
Distributed department reports and set up daily and monthly batch process
and backup tapes.
Education & Technical Skills
THE CHUBB INSTITUTE, Jersey City, NJ, Diploma in Technical Support, 1998
Microsoft Certified Professional (MCP)-Windows NT Server and Workstation,
Network Design(Needs Evaluation, Strategic Planning, Technology Deployment
General IT Skills-Web Applications, Networking Essentials, Project
Management, End-user Support, Hardware & Server Troubleshooting, Operating
Systems
Software-Adobe Acrobat, Documentum, eRoom, eSub, ISIToolbox, Norton Ghost,
Diagnostic Tools, Microsoft SharePoint, Microsoft Office, Lotus Notes
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