Centralized Study Specialist I Full-time Job
Nov 30th, -0001 at 00:00 IT & Telecoms Pune 27 views Reference: 3592Job Details
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. 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.
To complete other duties/activities as assigned by study management team, but not limited to:
 Manage clinical systems & access management
 Manage study documents and support eTMF management
 Maintain study databases (CTMS, IWRS, EDC etc.)
 Support study team in data review and support activities.
 Track and follow up with CRAs for outstanding issues
 Support in generating the study specific reports.
 Manage internal/external communications
 Assist in ensuring training compliance for study teams  Manage study payments (Site and Vendor)
 Data Review:
Follow up with CRA for resolution of the outstanding issues/action items related to assigned tasks. Assist the Lead for any study specific data review related tasks. Draft and send study specific reports as per the study team instructions. Perform any other data review related tasks as per the project team instructions.
