Senior Analyst Clinical Data -New Delhi

JOB DESCRIPTION :

Represents Data Management as the clinical database and data management subject matter expert on Clinical Project Teams through the following :

• . Attend Clinical Project Team meetings to gather business need requirements and translate to technical requirements
• . Partner with other shared service functions such as Safety, Core Lab, etc. to gather business need requirements and translate to technical requirements
• . Identify, analyze, propose solutions, and effectively resolve complex data issues by exercising appropriate judgment and collaborating with the clinical project team members and other shared service functions
• . Train database End Users (internal and external users) on the database and / or maintain automated database training system
• . Capture and maintain Database and Systems training records
• . Assists in FDA and Quality audits that involve Clinical Database and Data Management
• . Lead development and quality control (QC) of data management documents including data management plans, data review guidelines, and database validation protocols
• . Follows and implements data management standards and best practices and assures Standard Operating Procedures are followed for Data Management activities

Contributes to the development and maintenance of Clinical Database systems, including EDC, Edit Checks, Reporting, Study Notifications, Security, etc. through the following :

Serves as a data management expert and works with Biostatistics and Programmers to develop, promote, and ensure standards are utilized correctly in the database and system

Lead data cleaning and data freeze / lock efforts for regulatory submissions and other business needs as requested by the Clinical Project Team through the following :

The base pay for this position is

N / A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY :

Clinical Affairs / Statistics

DIVISION : MD Medical Devices

LOCATION :

India New Delhi : No. 100, 1st Floor, Okhla Industrial Estate, Phase III

ADDITIONAL LOCATIONS :

WORK SHIFT :

Standard

TRAVEL : Not specified

MEDICAL SURVEILLANCE :

Not Applicable

SIGNIFICANT WORK ACTIVITIES :

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)