Senior Clinical Data Analyst

FTINDDDBLR Fortrea Development India Private Limited_BLR; Bengaluru; Hybrid; INR 600,000 - 900,000; Full time

Job summary

Fortrea Development India Private Limited is seeking a Data Management professional to coordinate clinical data review, query management and reconciliation in support of project timelines and quality standards. The role involves developing data management plans, testing data systems and acting as back-up to the Clinical Data Manager.

You will work in an office/home-based environment in Bengaluru, with duties including generating study status reports, data extracts and supporting investigator

Qualifications

• University / college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution.
• Fluent in English, both written and verbal.
• Knowledge of medical terminology.
• Demonstrate time management skills and ability to adhere to project productivity metrics and timelines.
• Demonstrate ability to work in a team environment and collaborate with peers.
• Demonstrate good organizational ability, communication and interpersonal skills.
• Demonstrate team working and good collaboration skills.
• Knowledge of drug development process.
• Knowledge of effective clinical data management practices.

Responsibilities

• Coordinates clinical data review, query generation/resolution and reconciliation to support Data Management lead.
• Assist in development of Data Management Plan and data management system setup.
• Back-up to Clinical Data Manager and oversight of data management activities.
• Ensure data management tasks adhere to SOPs and GCPs and meet timelines.
• Generate, resolve and track data queries and listings; run programs and SAS tests.
• Support training of new staff and maintenance of eTMF and documentation.
• Assist with Database Lock activities and slide creation for meetings.

Skills

English fluency

Time management

Team collaboration

Organizational skills

Communication

Data review

Medical terminology

Education

University/college degree or allied health certification

Job description

Job Overview

Serve as a member of the project team with primary responsibility for coordinating the clinical data review, query generation / resolution and reconciliation activities to support the Data Management lead with the delivery of clinical data according to client quality and integrity specifications, project timelines and productivity targets. Assist in the development of the project Data Management Plan, including data review guidelines /diagnostics specification and setup of the data management systems according to project requirements. Serve as back-up to Clinical Data Manager, with oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, project timelines and budgets.

Summary of Responsibilities

• Ensures that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
• 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 within stipulated timelines.
• Assist with reviewing 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 aggregate data review activities.
• Run and execute additional programs, special listings, reconciliation discrepancy listings etc.) 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 review of data listings for internal data review.
• 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.
• Modify standard templates to create study specific Data Management Plans, or eCRF completion guidelines.
• Support team members by creating forms/memos as required.
• Posting of Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required.
• Generate study status reports.
• Perform database extracts.
• Assist in the creation of slides for Investigator Meeting and Site Initiation Visit or similar meetings.
• Assist with the completion of Database Lock activities.
• Support the training of new staff on project specific Data Management processes.
• 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.
• Fluent in English, both written and verbal.
• Knowledge of medical terminology.
• Demonstrate time management skills and ability to adhere to project productivity metrics and timelines.
• Demonstrate ability to work in a team environment and collaborate with peers.
• Demonstrate good organizational ability, communication and interpersonal skills.
• Demonstrate team working and good collaboration skills.
• Knowledge of drug development process.
• Knowledge of effective clinical data management practices.

Experience (Minimum Required)

• 2 to 4 years of applicable experience in clinical research (Data management preferred). Additional experience may be substituted for education requirements.

Preferred Qualifications

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

Physical Demands / Work Environment

Office and/or home-based work environment.

Learn more about our EEO & Accommodations request here.

At Fortrea, we're all about turning the "impossible" into "I'm possible". Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.