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Career domainClinical research · Trial data

Clinical Data Management

Clinical trial data management and statistical analysis is an area that is growing rapidly in India — ensuring the validity of clinical trial data and formatting it for statistical purposes.

CRFsCase report forms

DatabasesSet-up and management

CodingSOPs & dictionaries

AuditsAs per SOPs and GCP

To know more about the Clinical Research course, call +91 888-690-4030

Preferred e-Campus

Bangalore
Pune
Hyderabad
Mumbai
Delhi / Noida

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The industry

A growing hub for clinical trial data

India has developed into a super power for IT skills and has become a major hub for pharmaceutical and biotech manufacturing and contract research. The outsourcing business in various other segments is also exhibiting promise. Clinical trial data management and statistical analysis is one such area which is growing rapidly, accompanied by a variety of players entering into different models of this business.

IT skillsIndia has developed into a super power for IT skills.

Pharma hubA major hub for pharmaceutical and biotech manufacturing and contract research.

Rapid growthClinical trial data management and statistical analysis is growing rapidly.

New modelsA variety of players are entering different models of this business.

Work profile

Clinical Data Analyst / Manager

The primary responsibility is to ensure the validity of clinical trial data and format them for statistical purposes.

01

Study set-up

Designs collection instruments, sets up databases and tracks and manages the flow of data to and from the investigative sites.
With supervision, establishes protocol-specific data review and entry guidelines to document data validation and formatting procedures and defines batch-ending programs.

02

Data entry & cleaning

Monitors timely data entry.
Ensures that incoming CRFs are tracked in a timely manner prior to safety review and upon manual review.
Reviews data discrepancies resolutions provided by the investigative sites and enters corrections in the database, as appropriate.

03

Review & reporting

Assists in the review of interim/final data listings prior to transmission to other groups or inclusion in interim/final reports.

04

Standards & quality

Is familiar with database management systems and the principles, organization and content of standard Case Report Form (CRF) libraries.
Is familiar with data coding of Standard Operating Practices (SOP) and coding dictionaries.
Conducts database audits according to established SOPs and is familiar with the implementation of GCPs.

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