Senior Analyst Clinical Data New Delhi

New Delhi - India

Monthly Salary: Not Disclosed

Posted on: 01-11-2025

Vacancies: 1 Vacancy

Job Summary

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:

Partner closely with DM Management Database Developers/Analysts and Programmers to drive database and system deliverables

Translate business requirements into technical requirements for eCRFs edit checks study notifications and customizations in the study database

Perform and document functional and/or user acceptance testing on study databases reports study notifications and database customizations

Ensure that appropriate data validation (edit check) specifications and quality control checks are implemented per study needs

Effectively communicate with the Clinical Project Team and other key stakeholders regarding the deliverable including timeline workaround etc.

Partner with other Data Management team members and DM Management to prioritize deliverables

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

Process database accounts and reviews accounts regularly to ensure integrity of database access and security

Recommend improvements to existing Clinical Data Management practices and procedures (SOPs Work Instructions) including identifying and recommending solutions for technology issues

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:

Lead data review meetings with the Clinical Project Team and Statistics to identify data cleaning issues and strategize cleaning efforts

Project plan interim and final database lock and data reviews; monitor overall data management tasks to ensure that timelines are met and that any issues are proactively identified and resolved

Coordinate and ensure completion of all aspects of data review including running validation procedures issuing queries database QC SAE Reconciliation medical coding and database closure activities per work instructions and SOPs as applicable

Design tools and reports to document data review and assist in data cleaning activities

Lead and document data freeze activities with the Clinical Project team Biostatistics and SAS programmer

Utilize existing tools/reports SQL and database UI to identify data issues and drive resolutions with the Clinical Project Team in a timely manner

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)

Required Experience:

Senior IC

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 share...