Clinical Data Analyst - CPS Data Management

Fortrea; Bengaluru; Hybrid; INR 600,000 - 900,000; Full time

Job summary

Fortrea in Bengaluru seeks a data management professional to perform data review, query management and reconciliation to support delivery of clinical data within client quality standards and timelines.

You will generate ancillary programs, assist with Edit Check Specifications, and test SAS reports. The role requires a life sciences or related degree and at least 2 years of relevant experience, with office or home-based work options.

Qualifications

• Minimum a university/college degree in life sciences, health sciences, information technology or related field.

Responsibilities

• Perform data management tasks including data review and query management to ensure quality standards.
• Assist with review of clinical trial data per Data Management Plans and guidelines.
• Generate, resolve and track queries to address data issues identified during reviews.
• Create ancillary programs (diagnostics, listings) to support data review.
• Collaborate with project team for setup, maintenance and closure of Data Management tasks.
• Assist in creating/editing Edit Check Specifications.
• Create dummy data to test edit checks, database screens, and SAS reports.
• Document Data Management activities and maintain eTMF as required.
• Generate study status reports as assigned.
• Perform other duties as needed.

Skills

Interpersonal skills

Communication

Teamwork

Organizational skills

Collaboration

Education

Life sciences degree

Tools

SAS

eTMF

Job description

Job Overview

Perform data management activities such as clinical data review, query generation / resolution and reconciliation activities to support the Lead Data Reviewer/LDM with the delivery of clinical data according to client quality, project timelines and productivity targets.

Job Overview

Perform data management activities such as clinical data review, query generation / resolution and reconciliation activities to support the Lead Data Reviewer/LDM with the delivery of clinical data according to client quality, project timelines and productivity targets.

Summary Of Responsibilities

• Perform all data management tasks as appropriate to include, but not to be limited to data review and query management to ensure that quality standards (both internal and client) are achieved.
• Assist with review clinical trial data in accordance with Data Management Plans, Edit Check Specifications and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete data.
• Generate, resolve, and track queries to address problematic data identified during data review activities.
• Generate ancillary programs (diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.
• Interact with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project and attend meetings as required.
• Assist with creation/reviewing Edit Check Specifications.
• Assist or create dummy data to test edit checks and to test database screen design and functionality.
• Assist or create dummy data to test SAS reports and data listing.
• Posting of Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required.
• Generate study status reports as assigned.
• Performs any other duties as assigned.

Qualifications (Minimum Required)

• University / college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution.

Experience (Minimum Required)

• Minimum of 2 years of relevant experience
• Demonstrated interpersonal skills.
• Good oral and written communication skills.
• Demonstrate ability to work in a team environment and collaborate with peers.
• Demonstrate good organizational and interpersonal skills.
• Demonstrate team working skills, and good collaborator skills.
• Additional experience may be substituted for education requirements.

Preferred Qualifications Include

• Knowledge of Fortrea and the overall structure of the organization.
• Knowledge of Fortrea standard operating procedures.

Physical Demands/Work Environment

• Office and/or homebased work environment.

Learn more about our EEO & Accommodations request here.