Data Management

Usha priyadarshini.Ogirala

***,******* ******,

Jersey city,NJ-07307

Tel# 201-***-****

E-mail: ************@*****.***

Career Objective : Seeking a position as Clinical Data Coordinator in highly reputed and professional organisation.

Combine resourcefulness and problem solving with good analytical skills of clinical knowledge,

hardworking and requirements to adaptable to changing consistently deliver improved research and

production results. Team player dedicated to quality, continuous improvement and bottom-line

objectives.

To be competent and successful forerunner in this competitive environment - achieved through

involvement, perseverance and commitment.

Summary:

Overall around 18 months of experience in Clinical Data Management.

Knowledge of Drug development process.

Exposure to Clinical Data Management and Clinical Trial Process.

Knowledge of clinical Trial data likes Demographic Data, Adverse Events (AE), Serious Adverse Events (SAE),

and Laboratory Data (Lab Data), EDC work flow process and Study Build, CRF Development Specifications and

Designing, Data Validation Plan Specification

Good Comprehension of FDA and CDISC Guidelines, Good Clinical Practice’s(GCP), International Conference

of Harmonization (ICH) and Other Regulatory guidelines

Knowledge of 21 CFR, Good Clinical Data Management Practice (GCDMP), Interpretation of Protocol

Knowledge of all the important regulations and guidelines in Clinical Research (GCDMP, Sch Y, ) and Data

Management specific SOP’s.

Knowledge of complete clinical data management activites.

Qualifications:

1.Huge experience in Clinical Data Management, Deep Knowledge of medical and clinical trial terminology.

2.Profound knowledge of database technologies and Proficient with Database technologies.

3.Remarkable ability in maintaining medical records and patient proprietary data.

4.Ability in using Oracle Clinical RDC and phaseforward Inform to enter and query data in a clinical

database.

5. perform all clinical data cleaning activities on assigned projects,

6. Identify errors and inconsistencies in clinical trial data, resolve them or initiate their resolutions.

Job Duties

Clinical Data Coordinator 1, June 2010-January 2012

Moksha Biosciences –Hyderabad,INDIA

• Ensuring the completeness, consistency and quality of the clinical trial data that has gone through data entry.

• Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual

checks/listings.

• Assist with the validation of edit check programs.

• Experience in EDC systems like Oracle Clinical-Remote Data Capture (OC-RDC) and Phase Forward InForm.

• Discrepancy management in EDC as well as paper based studies.

• Practical Knowledge in Oracle Clinical as per the profile.

• Discrepancy Management – Manual and System Query generation, Sending Queries to the sites, reviewing and

Closing the answered queries.

• Accurately and consistently apply data handling conventions to Case Report Forms as necessary in accordance

with all applicable procedures.

• Compile and applicable procedures distribute necessary study documentation and maintain accurate and complete

study files in accordance with all applicable procedures.

Independently and accurately generate data discrepancies to resolve queries.

• Appropriately address responses to data queries and accurately update the clinical dataas necessary.

• Perform Serious Adverse Event reconciliation in accordance with all applicable procedures.

Perform external data reconciliation (Lab Reconciliation, ECG Reconciliation) in accordance with all applicable

procedures.

• Independently and accurately review Case Report Form data for completeness,accuracy and consistency in

accordance with all applicable procedures

• Understanding CRF completion guidelines.

• Identify and accurately resolve all workflow or clinical data discrepant issues.

Appropriately address responses to data queries and accurately update the clinical data as necessary.

Generate,review for accuracy and distribute status reports as requested.

Educational Background:

Bachelor’s degree in Pharmacy(B.Pharmacy)-2010

Vignan Institute of Pharmaceutical Technology,JNTUK

Visakhapatnam,Andhra Pradesh,INDIA

First class with Distinction

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