Clinical Data Specialist
21 hours ago
Job Title: Clinical Data Specialist
Location: Bengaluru, Karnataka, India (Remote)
Contract Type: Full-time
Seniority Level: Mid-Senior level
We are seeking a skilled Clinical Data Specialist to join our team at Fortrea, a leading global contract research organization. With a passion for scientific rigor and decades of clinical development experience, we provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.
Responsibilities:
- Ensure all allocated projects are carried out in accordance with protocols, global harmonized SOPs, and specified standards of GCPs.
- Demonstrate capability to read and follow study timelines for on-time deliverables.
- Assist with inputs on study design or make suggestions 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, incomplete data.
- Run additional programs used 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 project team members to support set-up, maintenance, and closure of Data Management aspects of the project.
- Generate and QC data listings for internal data review.
- May assist or create dummy data to test edit checks and database screen design and functionality.
- Assist or create dummy data to test SAS reports and data listing.
- Demonstrate ability to review Edit Check Specifications and Database specifications.
- Post Data Management documentation and administrative tasks as requested.
- Run study status reports in preparation for Sponsor meetings.
- Assist with completion of Database Lock and Unlock activities.
- Support training of new staff on project specific Data Management processes.
Requirements:
- 3-5 years of relevant work experience with increasing responsibility in data management and knowledge of one 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.
About Fortrea:
Fortrea is a talent-hiring platform in Life Sciences, Pharma, and IT that connects talent with opportunities in pharma, biotech, health sciences, healthtech, and IT domains. We strive to revolutionize the development process, ensuring swift delivery of life-changing ideas and therapies to patients in need.
Benefits:
- A competitive salary range of ₹1,200,000 - ₹2,000,000 per annum, depending on experience.
- Ongoing professional development and training opportunities.
- A collaborative workspace where personal growth is nurtured.
- The opportunity to make a meaningful global impact.
How to Apply:
Please visit our website to apply for this role and view similar positions.
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