Name: Mini Mathew

Address: **** ******** *****

Woodstock, GA 30189

Phone Number: 678-***-****

E-MailAddress:

ablxag@r.postjobfree.com

HIGHLIGHTS OF SKILLS AND EXPERIENCES

Regulatory

. Overseen the collection and submission, tracking, expiration, and

updates of all regulatory documents for various clinical trails.

. Assisted in overseeing and auditing the maintenance of all regulatory

files for multiple clinical studies for submission to sponsors, IRBs

and FDA.

. Assisted in the submission of regulatory copies and QA activities (GMP

GCP, and SOPs) for Oncology, Renal studies.

. Reviewed and maintained regulatory documents at various sites and for

FDA submission.

. Writing and implementing GMP, GCP, GLP, and SOPs and work practices

for (Phase I-IV) studies.

. Ensure sites follow GCP guidelines and performed site Interim and

close out visits.

. Responsible for maintaining contemporary regulatory policy and drug

development practice for various studies.

Clinical Research Associate

. Site Recruiting and co-monitoring activities at clinical study sites

to assure Good Clinical Practices, SOPs and Study Protocols.

. Primary responsibility is for site management and performance

including documentation.

. Assisted in Site management activities including all in-house and on-

site monitoring for all visit types.

. Conducts site visits as required pre-study, initiation, interim, and

close-out visits including site visit reports.

. Preparation of site-visit reports including all the visits from the

study start-up to the closeout.

. Reviewing and designing of the case report forms and Informed consent

forms

. Participated in the study development and start up process by

reviewing and designing case report forms, preparing Informed Consent

Forms, developing study documents and working with management on

monitoring strategy.

. Contributing input to design of clinical studies, from protocol

development through Case

Report Forms, ensuring safety and consistency with business and

regulatory requirements.

. Manage clinical study sites effectively monitoring resources and

timelines, resolving and

ensuring that the sites are adhering with data integrity, and meeting

the study requirements

by and enrolling study subjects, Investigators, on a timely manner and

ensuring their

understanding of requirements and procedures.

. Filing and collating trial documentation and reports.

. Identifying issues throughout the study duration, facilitating quick

resolution, and

documenting and reporting deviations

. Managing communications and acting as a liaison between sites and the

sponsor regarding all

aspects of clinical studies.

. Communicating with appropriate clinical research personnel to

minimize errors that affect

Study integrity and business outcomes.

Safety Coordinator

. Reviewed and prepared non-serious adverse events and serious adverse

events reports for FDA submission.

. Screened serious adverse events and reviewed Narratives.

. Post Marketing Reports of non serious reports and serious adverse

event listings for FDA submission.

Medical Coding

. Coding of medications, serious and non serious adverse events using

MedDRA, COSTART, WHO-DRUG dictionaries for FDA submissions.

. Assign ICD-9-CM and CPT codes for diagnostic procedures

Data Management

. Responsible for the creation of training Manuals, CRF Completion

Guidelines, Data Entry Guidelines, Edit Check Specifications, and also

in training other clinical professionals in various aspects of Data

Management.

. Responsible for overseeing the status of data entry of patient

profiles, Query status. Query resolution, and maintaining a clean data

for FDA submission.

. Proficient in capturing of patient data electronically from various

sites, Lab data,

. Serious Adverse Events, analyzing cleaning for data locks and

submissions to sponsors.

Computer Knowledge

Knowledge of computer applications including Microsoft Windows, Word,

Excel, PowerPoint, Access, Clintrial (Different versions), SQL Plus, Oracle

Clinical, Basic SQL Programming, and SAS language.

Therapeutic Experience:

. Oncology

. Neurology- Alzheimer, Multiple Sclerosis; Pain /Analgesia - Controlled

Substance

. Infectious Disease

. HIV and associated Opportunistic infections

. Central Nervous System

. Human Papillomavirus Vaccine, Prostate Cancer Prevention, Acute

Myeloid Leukemia, Metastasis Breast Cancer, Non-Hodgkin Lymphomomia

. Other: Cardiovascular-Hypertension-Angioplasty; Immunology - Chronic

Fatigue Syndrome; Urology- Overactive Bladder; Woman's Health-

Osteoporosis

. Device: Respiratory Devices, Contrast Agents

PROFESSIONAL PROFILE

Lexai Clinical

South Plainfield, NJ

01/2009-08/2009

Lead QC Specialist

. Ensure consistency and accuracy of data in Oracle Clinical (RDC) all

across the study.

. Review of Edit Checks on all Data sets to ensure quality and accuracy

per sponsor's guidelines.

. Manual QC of Case Report forms including Adverse Events, Serious

Adverse events, Concomitant Medications, Medical History, Dosage

Administration pg, Non Serious Adverse Events, Physical Exam, and

Medical Coding for Phase I studies.

. Execute data management processes such as Data Review, Query

Resolution for Oncology Studies using Oracle Clinical for Phase I

studies.

. Serve as primary contact person for the Sponsor, Programmers and Data

Managers for study related study issues.

. Create and approve Data Management Plan, Data Entry Guidelines, Edit

Specs, and Self Evident Corrections.

. Ensure consistency of coding across and within projects with

particular emphasis on Adverse Events and medications manually using

MeDra and WHO Dictionaries.

Beardsworth Consulting

06/2008 - 09/2008

Project Coordinator/ Medical Coder (Contractor)

. Ensure consistency of coding in TMS across and within projects with

particular emphasis

on adverse events and medications manually using MeDra and WHO

Dictionaries.

. Consult with Clinical Team leaders, Medical Advisors, Programmers to

resolve

coding issues.

. Develop and maintain excellent knowledge of medical and therapy terms

using

appropriate therapy tools such as Internet and electronic

dictionaries.

. Participated in initiatives to improve the coding processes and

systems.

. Locking Subjects by ensuring all case report pages received, reviewed

and all

queries resolved in Oracle Clinical (RDC) system.

Pharmanet, Princeton

05/2007-10/2007

.

. Reviewed, Wrote, issued and resolved queries in Oracle Clinical.

. Performed quality assurance of medical records and case report forms.

. Reviewed Annotated Case Report Form Data for various protocol

according to the protocol guidelines.

. Communicated discrepancies with Lead Data Mangers, Clinical Team and

coordinators.

Covance, Princeton, NJ

11/2006 - 05/2007

Clinical Data Manager (Contractor)

. Manual QC of Case Report forms including Adverse Events, Serious

Adverse events, Concomitant Medications, Medical History, Dosage

Administration pg, Serious Adverse Events, Non Serious Adverse Events,

Physical Exam for a Phase III Oncology Trail.

. Responsible for quality control of all Safety checklists, Serious

Adverse Events, Non Serious Adverse Events, Queries, to provide clean

Subject data to meet the dead line for the lock.

. Record quality control checks on formalized QC checklists that are

maintained as permanent records.

. QC of med names, adverse event terms, writing up for split terms, and

making obvious corrections for misspelled medications.

. Executed data management processes such as Data Review, Query

Resolution for Oncology Studies using Oracle Clinical for Phase III

studies.

. Performed discrepancy management activities as needed, based on output

generated from the batch validation specifications

. Performed updates in QMS (Query Management System) resulting from

returned DCF's/SDC's/listing reviews/coding feedback/etc.

. Executed data management processes required to lock study database.

Sanofi-Aventis, Bridgewater, NJ

07/2006 - 12/2006

Senior Study Research Manager /In-house Clinical Research Associate

(Contractor)

. Executed data management processes for Phase I studies including

creating Data Management Plan, Data Review Report, CRF Specs, Design

CRF pages.

. Collected and prepared information from various members of the project

team for IND submission to regulatory agencies.

. Reviewed final drafts of regulatory documents to ensure compliance and

consistency.

. Reviewed source documentation to determine inconsistencies against the

CRF.

. Wrote, issued, and resolved issues and generated the necessary queries

in Inform EDC SYSTEMS.

. Verified the accuracy of SAE's from CRF's in conjunction with the Med

watch report.

. Interacted with the Director of Clinical Research and other team

members to resolve laboratory discrepancies and toxicity grades for

reporting SAE's and AE's.

. Loading of external lab data, lab Reconciliation and SAE

Reconciliation.

. Creation and testing of database validations; review of study data;

generation and submission of data discrepancies; updates to database.

. Perform day-to-day data management activities for accuracy, data

integrity, and compliance with the company's SOPs for specific

studies.

. Locked Phase I Study, and provided clean Subject data, provided all

criteria for clean data such as resolution of all lab inconsistencies,

SAE Data, Medical Coding, all queries resolved and met the dead line

for the lock.

. Maintained regulatory copies and IRB copies for the data lock and FDA

approval.

. Compile and supplied Safety Reports, safety information for Regulatory

submissions such as Annual reports /clinical trial reports.

. Served as back-up to Sr. Data Manager in the preparation of periodic

safety reports, and in generation and maintenance of standard SOPs and

working guides.

Abbott Laboratories, Parsippany, NJ

12/2005 - 06/2006

Study Data Manager/Consultant

. Review reports, database listings, and any other potential sources for

identification of protocol deviations.

. Coordinated Psoriasis study by creating study start up

documents: Study Plan, Data Handling Plan, and Data entry guidelines.

. Involved in all data management activities/objectives for CRF process

flow and query resolution in Oracle Clinical RDC systems.

. Served as primary contact person for Clinical, Programmers and Data

Entry for Data Management related to Psoriasis study issues.

Novartis Pharmaceutical, East Hanover, NJ

07/2005 - 12/2005

Research Pharmaceutical Services

Clinical Data Manager/Consultant

. Perform data review and cleaning using Inform EDC (EDC) system.

. Closes any resolved queries, Freezes data once they are complete and

queries have been resolved in home based EDC system.

. Enters and maintains Protocol Violations in the database.

. Used Integrated Review for creating various listings in different

tables such as Medical History, Concomitant Medications, Non Serious

and Serious Adverse Events.

PharmData/ Premier-Research, Marietta, GA

Clinical Research Coordinator

11/2004-2005

. Responsible for monitoring all types of clinical trials; assures

adherence to Good Clinical

practice, investigator integrity and compliance with all study

procedures.

. Primary responsibility is for site management and performance,

including documentation.

. Site management activities include all in-house and on-site monitoring

for all visit types.

. Conducts site visits as required pre-study, initiation, interim, and

close-out visits including site visit reports.

. Perform data review by generating Queries and Medical coding using

MeDdra and Who Drug Dictionaries.

. Perform updates to data resulting from the returned queries from site,

listings and manual review.

. Collected patient data from local sites. .

. Compile listings of deviations for each patient, Categorize each

protocol deviation based on pre-defined classifications.

. Communicate progress in compiling protocol deviation listings to the

Lead CRA and/or Sr. Manager.

. Provide deviation listings for each study in the required format to

the Lead CRA and/or Sr. Manager by the agreed upon timelines.

. Review study related documentation to follow-up on any issues

identified by the study management team.

. Wrote consumer narratives of non-serious and serious events for FDA

submission.

. Review of draft protocols for clients in conjunction with Project

Manager

. Performed basic reporting of data via SAS and produced summary tables.

Bone Care International Inc. Middleton, WI

Pharmaceutical Company

Clinical Data Manager/ Clinical Research Associate (3/2002 - 3/2003)

. Coordinated timeline for completion of the system Implementation.

. Project Management of Oracle Clinical System Installation, Validation

and Implementation.

. Responsible for Site Monitoring in all types of Monitoring visits.

. Independently coordinated and managed a clinical study by assigning

tasks for each CRA.

. Coding of Adverse events and Medications both manually and using

MeDdra.

. Responsible for coordinating serious adverse event review, tracking

and report activities.

. Post Marketing Reports for Non Serious and Serious Adverse Events for

FDA Submission.

. Assisted in Serious Adverse Event Narratives and entering them using

Med Watch forms.

. Assisted in the creation of Informed Consent forms, Protocol writing

and Case Report forms.

. Responsible for the preparation of Standard Operating Procedure (SOP)

for Data

Management.

. Responsible for performing the CRF Database Audit, Project Tracking,

Reviewing tables,

for final database lock.

. Ad -hoc and standard query generation, and also querying clinical

investigators both internal

and external for the completion and accuracy of study data.

. Acted as focus person for the Data Management department to interact

with CRA managers,

Clinical, Regulatory Affairs, programmers and other members of

clinical operations.

. Assisted with QC audit during preparation of clinical review for final

project.

. Assisted in Protocol writing, Budget preparation, proposals, for

various projects- (Oncology,

. CNS, Infectious Disease etc).

. Contributing input to design of clinical studies, from protocol

development through case

. Report forms, ensuring safety and consistency with business and

regulatory requirements.

. Manage clinical study sites effectively monitoring resources and

timelines, resolving and

. ensuring that the sites are adhering with data integrity, and meeting

the study requirements

. by and enrolling study subjects, Investigators, on a timely manner and

ensuring their

. understanding of requirements and procedures.

. Filing and collating trial documentation and reports.

. Identifying issues throughout the study duration, facilitating quick

resolution, and

. documenting and reporting deviations

Novartis Pharmaceutical, East Hanover, NJ

Research Pharmaceutical Services (RPS)

Clinical Data Manager/ Consultant (03/2001 - 10/2001)

. Project leader of a team for STI106 (Oncology Drug) by coordinating

different international

team operations.

. Coordinate timeline for completion of editing of database closure to

meet the deadline.

. Supervise Clinical Data Specialists, Data processors and QC

Specialists.

. Assign projects and work with other Data Specialists and coordinators

to meet project

deadlines.

. Provide training for new Clinical Data Coordinators, and Data

Specialists.

. Acted as focus person for the Data Management department to interact

with CRA managers,

clinical, programmers and other members of clinical operations.

. Querying clinical investigators both internal and external for

completeness and accuracy of

report forms in Clintrial. (Version 4.2)

. Maintained assorted database through computer checks, quality

assurance and validation of

various protocol specific databases.

. Involved in the process of data managing, data resolving and data

validation & Retrieval.

. Conducted d monitored periodic team meetings to assess project status,

assign new projects to

members and teleconferencing with international teams.

. Maintaining the Regulatory copies and IRB copies for the Data Lock and

the FDA Approval.

World Wide Clinical Trials Kennesaw, GA

Project Coordinator/Clinical Research Associate (08/1997 - 08/2001)

. Assume primary responsibility for data management activities in Oracle

Clinical system for numerous Protocols.

. Coordinate timeline for completion of editing for database closure.

. Entering Patient Profile for SAE Narratives for ongoing studies.

. Assign projects and work with other Data Specialists and coordinators

to meet the project

deadlines.

. Provide training for new Clinical data coordinators, data specialists

on testing data entry

screens, forms, conversion procedures and monthly data reports.

. Issued, Resolved and Closed queries in Oracle Clinical Data Management

System .

. Identifying and coding adverse events using costart dictionary and

MedDRA.

. Work with CRA's and CRA managers for the resolution of data queries.

. Develop Study Specific Data entry guidelines and reconcile lab data.

Covance Radnor, PA

Clinical Research Associate (Contractor) (03/1997 - 09/1997)

. Reviewed, and resolved study data inconsistencies by sending queries

to the sites for different

clinical studies.

. Assisted with QC audit during preparation of clinical review for final

project.

. Maintained completed study files for various studies being processed.

. Evaluated clinical data recognizing inconsistencies with departmental

and protocol specific

guidelines.

. Identified critical issues and interacted with other departments to

clarify and resolve

discrepancies.

. Consulted with physicians regarding processing of various report

inconsistencies.

. Researched, compiled and analyzed data elements for statistical and

medical reviews in Clintrial.

. Monitoring a site and collecting all the patient data for all visits.

Covalent Research Alliance Valley Forge, PA

Clinical Research Consultant (01/1996 - 03/1997) (Contractor)

. Monitoring the sites, collecting the Patient data from various sites.

. Verification and Data entry of Case Report Forms in Clintrial.

. Responsible for Data retrieval and running listings.

. Training data entry personnel on data entry and verification of

specific pharmaceutical trial protocols.

. Maintained and updated files for database proficient in

Clintrial/Oracle database with good knowledge of SQL programming.

. Proficient in co-start and WHO dictionaries. Assisted in coding

medication and adverse events.

. Querying clinical investigators both internal and external for

completeness and accuracy of Case Report Forms.

. Maintained assorted databases through computer checks, quality

assurance and validation of various protocol specific databases.

. Testing of database to insure proper entry for development of database

in Clintrial.

. Interacted with clinical, statistical and programmers, resolve and

answers questions concerning study specifics.

. Maintenance of regulatory and data management copies for the database

lock.

Education

Bachelor of Science in Biology

University of Kerala, Kerala State, India

Certificate in Phlebotomy (MLT) 1990

Montgomery Community College -1989-1990 (General Studies)

Bluebell, PA

Attended Temple University, Phila, PA (1991-92)

Pharmacy Studies

Configer Consulting, 2008

Basic SAS Training

Premier Clinical Research, Marietta, GA Introduction to Clinical

Monitoring, CRA GCP, Core Clinical and Data Management Training, 2005

Professional Affiliations: Association of Clinical Research Professionals,

Society for Clinical Research Associates.

Contact this candidate