Home
Communities
Companies
- Companies
  
  Discover best places to work
- Compare Companies
  
  Compare & find best workplace
- Add Office Photos
  
  Bring your workplace to life
- Add Company Benefits
  
  Highlight your company's perks
Reviews
- Company reviews
  
  Read reviews for 6L+ companies
- Write a review
  
  Rate your former or current company
Salaries
- Browse salaries
  
  Discover salaries for 6L+ companies
- Salary calculator
  
  Calculate your take home salary
- Are you paid fairly?
  
  Check your market value
- Share your salary
  
  Help other jobseekers
- Gratuity calculator
  
  Check your gratuity amount
- HRA calculator
  
  Check how much of your HRA is tax-free
- Salary hike calculator
  
  Check your salary hike
Interviews
- Company interviews
  
  Read interviews for 40K+ companies
- Campus placements
  
  Interviews questions for 1K+ colleges
- Share interview questions
  
  Contribute your interview questions
Jobs
Awards

WINNERS AWAITED!
- ABECA 2025
  
  WINNERS AWAITED!
  
  AmbitionBox Employee Choice Awards - 4th Edition
- ABECA 2024
  
  AmbitionBox Employee Choice Awards - 3rd Edition
- AmbitionBox Best Places to Work 2022
  
  2nd Edition
- AmbitionBox Best Places to Work 2021
  
  1st Edition

Add office photos

Engaged Employer

Fortrea Development India Private Limited

Compare

3.9

based on 677 Reviews

30 Fortrea Development India Private Limited Jobs

Clinical Data Specialist

Fortrea

3.9

based on 677 Reviews

3-5 years

Bangalore / Bengaluru

1 vacancy

Clinical Data Specialist

Fortrea Development India Private Limited

posted 1d ago

Job Role Insights

Flexible timing

Key skills for the job

Cron Pharmacy Hospital Administration Information Technology Clinical Data Management Clinical SAS Programming

+ 3 more

Job Description

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Job Overview:

Serve as a member of the project team with primary responsibility for conducting 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 /edit check and eCRF specification. May contribute to setup of the data management systems according to project requirements.

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.
Demonstrates capability to read and follow study timelines for on-time deliverables.
Potential to assist with inputs on study design or capable to make suggestions to study timelines when warranted.
Assist with review of clinical trial data in accordance with Data Management Plans and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete data.
Run and execute additional programs (special listings, reconciliation discrepancy listings, etc.) used to support the review of clinical trial data.
Generate, resolve and track queries to address problematic data identified during aggregate data review activities.
Interacts 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.
Generate and QCs data listings for internal data review.
May 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.
Demonstrates the ability to review Edit Check Specifications and Database specifications.
Post Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required.
Runs study status reports in preparation for Sponsor meetings and to deliver on specific Sponsor request.
Assist with the completion of Database Lock and Unlock activities.
Supports 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.

Experience (Minimum Required):

3 to 5 years of relevant work experience with increasing responsibility in data management with knowledge of one (1) or more therapeutic areas.
Demonstrated time management skill and ability to adhere to project productivity metrics and timelines.
Knowledge of medical terminology is preferred.
Knowledge of effective clinical data management practices.
Knowledge of science or a scientific background is preferred.
Good oral and written communication skills.
Demonstrate time management skill 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 skills and good collaborator skills.
Demonstrate a constructive problem-solving attitude while deadline focused with time demands, incomplete information or unexpected events.