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About Company

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 with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Position Name :

Clinical Data Specialist

Organization :

Fortrea

Qualification:

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

Experience:

3 to 5 years

Salary:

₹8.5 Lakhs per year

Location:

Bangalore

Responsibilities

  • Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
  • Demonstrate capability to read and follow study timelines for on-time deliverables.
  • Assist with inputs on study design or suggest adjustments to study timelines when warranted.
  • Review clinical trial data in accordance with Data Management Plans and/or Data Review Guidelines and raise queries to resolve erroneous, missing, or incomplete data.
  • Run and execute additional programs (special listings, reconciliation discrepancy listings, etc.) to support the review of clinical trial data.
  • Generate, resolve, and track queries to address problematic data identified during aggregate data review activities.
  • 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.
  • Generate and QC data listings for internal data review.
  • Assist with or create dummy data to test edit checks and database screen design and functionality.
  • Assist with or create dummy data to test SAS reports and data listings.
  • 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.
  • Run study status reports in preparation for Sponsor meetings and to deliver on specific sponsor requests.
  • Assist with the completion of Database Lock and Unlock activities.
  • Support the training of new staff on project-specific Data Management processes.
  • Perform any other duties as assigned.

Application Link