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Data Management Clinical

Location:
Binnipete, Karnataka, 560010, India
Salary:
As per the company's standard.
Posted:
March 30, 2024

Contact this candidate

Resume:

Anitharani N

Email: ad4oc1@r.postjobfree.com

Contact No: 990-***-****

CAREER OBJECTIVE

I have overall 10 Year 6 Months of experience in CDM ( 9 years in Medical coding with 3 Years 6 Months in Data Management). I am looking for a challenging position in Clinical Data Management in reputed company with a view to use my experience for the benefit of the organization. PROFESSIONAL EXPERIENCE: -

1. Accenture Bangalore

Oct 31st 2022 to till date

Designation: Clinical data management scientist

Roles in the projects

Roles and Responsibilities: -

Query Management (Query Raising, Query Closing, Re-querying)

Performed Listings Review, Query management, SAE Reconciliation, Lab data Reconciliation, vendor data Reconciliation, Tumor listing review.

Performed freezing and database lock, audit activities. 2. QUANTICATE INDIA PRIVATE LIMITED

April 20th, 2020 to Oct 2022

Role: Clinical Data Manager-I. Data Management

Roles and Responsibilities: -

Has good experience in the EDC database like RAVE (CLASSIC& X).

Query Management (Query Raising, Query Closing, Re-querying)

Performed Listings Review, Query management, SAE Reconciliation.

Understand, provide input to, and comply with all applicable sections of Data Management Plan.

Involved in communicating with internal and external customers.

Demonstrated capability of coding the Adverse events and Medications, Indications, Surgical Procedures, Medical History using MedDRA and WHODRUG as per timelines

Evaluates the record for documentation consistency and adequacy and ensure compliance with established coding guidelines.

Review all coded terms within the clinical database for accuracy and consistency and appropriately address coding discrepancies or inconsistencies

Management of all auto encoding and manual coding of medical terms and medications as specified by the sponsor.

Preparation and review various coding reports as required to ensure quality, consistency, accuracy of coding and manual review for specialized forms of data cleaning

Performed Coding UAT Validation and coder set up configuration activities in Rave.

Develop and maintain good communications and working relationships with CDM team.

Involved in MedDRA and WHODRUG Dictionary up versioning.

Involved in Process Improvement activities by doing study metrics, Quality Metrics.

Involved in providing inputs in the development of SOP’s, improvement initiatives and process.

Review of study data bases including data entry screens.

Managing Coding Team.

Documenting all the activities and working according to SOPs.

Creation of study status Reports and weekly status reports. 3. Accenture Bangalore

Sep 7th to Mar 20th, 2020

Designation: Medical Service senior Analyst- Data Management Roles in the projects:

Roles and Responsibilities: -

Demonstrated capability of coding the adverse events and Medications as per timelines

Evaluates the record for documentation consistency and adequacy and ensure compliance with established coding guidelines.

Creating coding queries and has good experience in the database ORACLE

Has good experience in Coding tools IN TMS

Involved in communicating with internal and external customers.

Review all coded terms within the clinical database for accuracy and consistency and appropriately address coding discrepancies or inconsistencies

Management of all auto encoding and manual coding of medical terms and medications as specified by the sponsor.

Preparation and review various coding reports as required to ensure quality, consistency, accuracy of coding and manual review for specialized forms of data cleaning

Understand and comply with core operating procedures and working instructions.

Understand basic database structures.

Develop and maintain good communications and working relationships with CDM team. 3. Quintiles (IQVIA) Research India Pvt.Ltd, Bangalore Jul 3rd, 2013 to 3rd Sep 2018

Role: Clinical Data Coordinator 1 - Data Management Roles and Responsibilities: -

Creating Data coding guidelines, performing Validation during coding set up of the tool.

Demonstrated capability of coding the adverse events and Medications as per timelines

Evaluates the record for documentation consistency and adequacy and ensure compliance with established coding guidelines.

Creating coding queries and has good experience in the database RAVE and INFORM.

Has good experience in Coding tools such as Q code, Medidata coder and DS Navigator.

Involve in communicating with internal and external customers.

Perform data review.

Query Management (Query Raising, Query Closing, Re-querying- Both DM, Auto Queries and Clinical queries)

Documenting all the activities and working according to SOPs. Other work experience

As a Dentist practiced in Private clinics for 5 Years I have worked as Clinical Research Coordinator for 2 years in Bangalore Medical Centre, Kalyan Nagar. THERAPEUTIC AREA

Oncology

Dermatology

Neurology

Gynecology

Cardiology

Endocrinology

EDUCATIONAL QUALIFICATION

● Bachelor of Dental Surgery (BDS)

J.S.S Dental College and Hospital, Mysore

Rajiv Gandhi University of Health Science,

Karnataka, India-570008, August 2001-May 2007

● MBA-HCS (Health care service)

Sikkim manipal university manipal. -2010

● Advance Diploma in Clinical Research and pharmacovigilance Clinotech India Jayanagar Bangalore-2010

● TECHNICAL EDUCATION: MS Office, Excel.

SKILLS

Ability to successfully work together in a team as well as independently.

Strong organizational skills, ability to manage competing priorities, and be flexible to change

Excellent analytical and presentation skills

Good communication and interpersonal skills.

Eager to adapt to a new environment at a personal and professional level.

Willingness to take up any assignment with enthusiasm and curiosity to learn new things PERSONAL DETAILS

DOB: : 15 June 1983

Nationality : Indian

Gender : Female

Father’s Name : Nagendra

Husband’s Name : Manjunath .N

Marital status : Married

Languages Known : English, Kannada, and Hindi, Telugu Address : #3419, 6THCross, Gayathrinagar, Bangalore DECLARATION

I hereby declare that all information furnished above is true to the best of my knowledge. Date:

Place:

ANITHARANI. N



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