Management Clinical

Sanket.S.Chavan

Mobile: +917*********

+919*********

Email-ID: *********@*****.***

Professional Summary

. PROFICIENT IN CLINICAL DATA MANAGEMENT.

. Highly motivated individual with excellent organizational and

interpersonal skills.

. Possess strong ability to quickly adapt to new applications and

platforms.

. Ability to give qualitative output with presenting and cope up with the

workload

. Ability to work under pressure, stress, and meet dead lines

. Ability to work in a team with high level of involvement

. Good understanding of International Conference of Harmonization/Good

Clinical Practice (ICH GCP) Guideline, FDA and CDISC guidelines.

. Good Knowledge Medical coding Dictionaries MedDRA and WHODRUG

. Good Knowledge of 21 CFR Part 11,Good Clinical Data Management Practice

(GCDMP)

. Thorough understanding of Clinical data management process

. Understanding of CDM SOP's

. Proficient in Oracle Clinical (OC)

. Understanding of Discrepancy Management

. Thorough knowledge of data validation processes (like Discrepancy review,

DCF life cycle etc.) including Quality control process

. Good understanding with CDISC SDTM Implementation Guide v3.1.1 / v3.1.2

and SDTM Model

. Good Comprehension of FDA and CDISC guidelines, International Conference

of Harmonization/Good Clinical Practice (ICH GCP) Guideline

. Good Knowledge of Clinical Trial Management System (CTMS) & all phases

(Phase I -IV) of clinical trial.

. Good Knowledge of 21 CFR Part 11, Good Clinical Data Management Practice

(GCDMP).

. Knowledge in understanding SOP's.

Technical Skills

CLINICAL DATA MANAGEMENT AND ORACLE CLINICAL SKILLS:

FUNCTIONAL RESPONSIBILITY:

. Code review medical terms in thesaurus management system

. Generate/review queries to clarify in order to facilitate coding

. Update the term using modify field when required

. Ensure that timelines for a particular study are related to coding are

meet

. Participate in study related meetings as needed

. Provide updates to study team lead in absence of team lead

. Submit new term addition request to dictionary administrator

. Perform TMS validation for various coding related applications as and

when required

. Participate in knowledge sharing sessions as and when required

. Ensure compliance to applicable SWP's

. Provide inputs in creation and maintenance of project specific coding

conventions

. Adhere to communication and risk /issue escalation pathways

. Ensure adherence to productivity and quality targets

. Contribute to process improvements

.

Tools Knowledge:

. Clinical Data Management System: Oracle Clinical 4.6

. Data bases : Oracle 9, Inform

. Operating System : Windows XP and Seven(7)

Work Experience

Company Name: Quintiles, Bangalore

Designation: Associate Clinical Data Coordinator

Duration: Feb 2014- till date

Responsibilites: . Performing coding activities in timely and

efficient manner.

SAE reconciliation of clinical and safety data.

Experience in working with Oracle TMS, Inform (5.5

V),SQL.

Working on 20+ studies.

Have worked in Psoriasis, Crohn's Disease, Neoplasm,

Cardiovascular disease and Diabetic studies.

Queries Management.

DCG preparation, validation of test and live data for

coding.

. Participate in study related meeting and providing

inputs as needed.

Company Name: Cognizant Technology Solution, Mumbai

Designation: Trainee Junior Data Analyst

Duration: April 2012 - Jan 2013(1.9 yrs)

Responsibilities: Performing coding activities in timely and efficient

manner.

Generate queries to clarify in order to facilitate

coding.

Participate in study related meeting as needed.

Experience in working with Oracle TMS,J review

Worked on 15+ studies

Have worked in Psoriasis, Crohn's Disease, Oncology,

Cardiovascular disease and Diabetic studies

Education & Certifications

TITLE OF THE DEGREE Year of Passing

College/University

Bachelor of Pharmacy Mumbai university Nov-2011

Registered pharmacist pharmacy council of

india

Personal Details

DATE OF BIRTH : 28TH MAY, 1989

Sex : Male

Marital Status : Unmarried

Nationality : Indian

Languages : English, Hindi, marathi

DECLARATION:

I hereby declare that all the details furnished herewith are true to the

best of my knowledge. The Reference and Originals will be presented when

attending the interview or on demand.

Sanket .S.CHAVAN

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