Data Management

DIPEN B. PATEL

908-***-****

*********@*******.***

EDUCATION University of Medicine and Dentistry of New Jersey,

Newark, NJ

. Masters in Clinical Trials Sciences, Regular Trial

Affairs, May 2012

. GPA - 3.85/4.0 - Honors

Rutgers, the State University of New Jersey, New Brunswick,

NJ

. Bachelor of Science in Biology, May 2008

. Study Abroad: Central Caribbean Marine Institute,

Little Cayman Islands 2008

EXPERIENCE Pfizer, Bridgewater, NJ 06/2012-

Current

Drug Safety Data Management Specialist

. Responsible for collection and processing of

spontaneous and clinical trial adverse events and

inputting data into ARGUS safety database

. Review processed cases to verify accuracy,

consistency, and compliance with process

requirements, and review case data for special

scenarios.

. Liaise with key partners, locally, and other

stakeholders regarding safety data collection and

data reconciliation

. Develop and maintain expertise and knowledge for

applicable corporate and global regulations, for

guidelines, Standard Operating Procedures, for data

entry conventions, and for search functions in the

safety database

Determine reportability of scheduled reports,

ensuring adherence to regulatory requirements

. Determine and perform appropriate case follow-up,

including generation of follow-up requests, writing

and editing the case narrative, and Carry out case

processing activities.

. Review case criteria to determine the appropriate

workflow for case processing and escalate

appropriately

. Review, rank, verify process and document case-

related information: event terms; validity,

seriousness, special scenarios; timelines; accuracy

and consistency.

UMDNJ, New Brunswick, NJ

01/2012-05/2012

Institutional Review Board, New Brunswick

. Institutional Review Board Internship

. Ensuring the protection of individuals who

participate in research;

. Ensuring compliance with all pertinent federal and

state laws and regulations

. Reviewing clinical trials for UMDNJ Human Subjects

Protection Program

Merck/Schering Plough Corp-Research Institute, Springfield,

NJ 03/2009-01/2010

Pharmaceutical Jr. Clinical Indexer-Clinical Documentation

. Categorization and attribution of clinical trials

files from central file using ORACLE-based systems

. Ensured e-documentation compliance with internal and

external (FDA) regulations, coding

. Database management, auditing, and case report

preparation

. Documentation consisted of general correspondence,

regulatory documents, case report forms, adverse

events, clinical study and statistical reports as

well as shipping documents

JFK Medical Center-Pharmacy Department, Edison, NJ

05/2003-Present

Certified Pharmacy Technician

. Prepare and deliver chemotherapeutic agents to

nursing stations

. Compound large-volume intravenous mixtures under the

HEPA Certified Hood

. Pre-pack bulk medications and supplies for dispensing

. Deliver drugs, pharmaceutical supplies, and automated

medication administration records to the nursing

stations

. Operate medication dispensing robot and fill

patients' medication cassettes

. Deliver medication to automated dispensing

technology, Omnicell

. Monitor inventory of the medications, chemicals, and

other supplies, and prepare orders for additional

quantities as needed

. Assist and train new pharmacy technicians and

clerical employees

SKILLS

. Knowledge of grant writing, NDA's and IND's, 510k's,

IDE's, MedDRA

. Highly proficient in Microsoft Word, Excel,

PowerPoint, Argus, Oracle-based Software, Java and

Adobe Photoshop

. Strong mathematical and computation skills

. Knowledge of recordkeeping techniques

Contact this candidate