Clinical Data Specialist at Fortrea
About Fortrea:
Fortrea is a leading global contract research organization (CRO) specializing in scientific rigor and clinical development. With over 19,000 staff across more than 90 countries, Fortrea partners with pharmaceutical, biotechnology, and medical device companies to transform drug and device development.
Position: Clinical Data Specialist
Organization: Fortrea
Qualification: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences
Experience: 3 to 5 years
Salary: Not disclosed
Location: Bengaluru, India
Key Responsibilities:
| Area | Tasks |
|---|---|
| Project Management | Ensure projects adhere to protocols, SOPs, and GCP standards – Read and follow study timelines for deliverables – Provide inputs on study design and timelines |
| Data Review | Review clinical trial data as per Data Management Plans/Data Review Guidelines – Raise queries for erroneous, missing, or incomplete data – Run and execute additional programs for data review |
| Team Interaction | Support set-up, maintenance, and closure of Data Management aspects – Attend project meetings – Generate and QC data listings for internal review |
| Edit Checks and Specifications | Assist or create dummy data to test edit checks and database design – Review Edit Check Specifications and Database specifications |
| Documentation | Post Data Management documents and perform administrative tasks – Maintain eTMF as required – Run study status reports for Sponsor meetings |
| Training and Support | Train new staff on Data Management processes – Assist with Database Lock and Unlock activities – Perform any other assigned duties |