Fortrea Clinical Data Management Position Available – Apply Online
Clinical Data Specialist
Location: Bangalore, India
Time Type: Full time
Job Requisition ID: 2440541
As a leading global contract research organization (CRO) with a commitment to scientific rigor and decades of clinical development experience, Fortrea offers pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in over 90 countries, Fortrea is transforming drug and device development for partners and patients worldwide.
Responsibilities:
- Ensure all allocated projects are carried out in strict accordance with relevant protocols, global harmonized SOPs, and specified GCP standards.
- Demonstrate the capability to read and follow study timelines for on-time deliverables.
- Assist with inputs on study design or suggest adjustments to study timelines when necessary.
- Review clinical trial data per Data Management Plans and/or Data Review Guidelines, raising 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 addressing problematic data identified during aggregate data review activities.
- Interact with other project team members to support the set-up, maintenance, and closure of Data Management aspects of the project; attend meetings as needed.
- Generate and QC data listings for internal data review.
- May assist or create dummy data to test edit checks, database screen design, and functionality.
- Assist or create dummy data to test SAS reports and data listings.
- Demonstrate the ability to review Edit Check Specifications and Database specifications.
- Complete Data Management documentation and perform data management-related administrative tasks as requested, including eTMF maintenance as required.
- Run study status reports in preparation for Sponsor meetings and meet specific Sponsor requests.
- Assist with Database Lock and Unlock activities.
- Support training of new staff on project-specific Data Management processes.
- Perform any other duties as assigned.
Minimum Requirements:
- 3 to 5 years of relevant work experience with increasing responsibility in data management, with knowledge of one or more therapeutic areas.
- Demonstrated time management skills and ability to adhere to project productivity metrics and timelines.
- Preferred knowledge of medical terminology.
- Understanding of effective clinical data management practices.
Fortrea seeks motivated problem-solvers and creative thinkers who share our passion for advancing clinical trials. Our commitment is to revolutionize the development process, ensuring the rapid delivery of life-changing therapies to patients. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
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