Gurpreet K Saini

Phoenix, Arizona *****.

(Cell no) 916-***-****

Email:aca4ca@r.postjobfree.com

Objective

.

To seek a career in a progressive Clinical Research organization, utilizing

acquired skills, knowledge and experiences with the goal of saving the life

of subjects.

Experience as Clinical Data Management coordinator

Approximately 6 years of Clinical Data Management Experience in

different care facilities of clinical research.

Clinical Data Management Coordinator

* Data entry of clinical data into the databases for multiple studies

within timelines.

* Review, Analyse and validate clinical trial data to ensure consistency,

integrity and accuracy based on project specific guidelines.

* Assist with the creation of Data review guidelines.

* Assist with the set-up of study files and the collection, filing and

archiving of study documents.

* Maintain clinical trial data accuracy through review of case report forms

for completeness and consistency.

* Assist in the development and implementation of strategy for data

cleaning.

* Carry out Query production, resolution and tracking to resolve

problematic Data identified during the review and update the database

accordingly.

* Strong Electronic Data Capture Experience of different Databases

including medidata Rave,,inForm,Viedoc,Dsg,Perceptive,OCRDC,medpace,PRAedc and Datatrak, worked

on these databases in entering data and Discrepancy Management and

implemented and validated oracle clinical Database.

* Perform Electronic Data Capture query Management using different

databases.

* Retrieved Case Report Forms and tracked query resolution for electronic

data capture as well as paper case report forms.

* Generate, track and resolve data queries using data clarification froms,

data cleaning specifications and various other data management

documentations.

* Ensured accurate tracking of all CRF's and DCF's and identify any missing

information.

* Participated in study start up and close out activities.

* In Depth technical management and tracking of data, discrepancy

resolution.

* Review Clinical Data in accordance with the company's SOPs and data

review conventions to identify erroneous, missing, incomplete or

implausible Data.

* QC and QA the source binders on regular basis for multiple studies making

sure source matches the CRF.

* Resolve queries generated by sponsors and CRA for multiple studies on

site within timelines as specified for the study.

* Preparing the site for Internal and External Audit.

* Preparing the site for close out for multiple studies and procuring study

documents.

* Assist with the Regulatory and perform other duties assigned by

Management.

* Assist other coordinators if needed and trial communication with

the sponsors.

* Assessment of inclusion/exclusion criteria

* Procure essential documents at the site.

* Interface with the study personnel to expedite

Resolution of queries and to improve quality of the data being collected.

* Data collection and management.

* Collection of source documents.

* Registration and Management of AE's.

* Interact with the clinical and study project team as necessary.

* Assisting in the final Report.

* Completing Financial Obligations.

Work Experience

Clinical Data Management Coordinator, Southwest Clinical Research,

Arizona. 09/2010-Present

Research Associate, Department of Neurology

Post Graduate Institute of Medical Education and Research, India

03/2009-03/2010

Clinical Data Management Coordinator, Department of Nephrology

Post Graduate Institute of Medical Education and Research, India

07/2007-02/2009

Achievements

.

* Successful coordination in preparing medical site for the audits

conducted by sponsor and an international independent audit

organization.

* Good Time Management skills and ability to work under tight timelines.

* Effective Communication Skills.

* Strong organizational skills and ability to prioritize.

* Good Knowledge of Computers.

* Competency in data management systems.

* Ability to adhere to strict guidelines and codes of practice.

Academic Qualifications &

Degrees

* Master Degree in Bioinformatics from Punjab University

Chandigarh(2007), India

* Bachelor Degree in Biotechnology from Guru Nanakdev University,

Amritsar(2005),India

* Advanced Secondary Diploma-Punjab School Education Board,Mohali(2002),

India

* Secondary Education -Indian Council Sciences and Education Board

Delhi,(2000),

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