TransPerfect Is More Than Just a Job… Our greatest asset is our people, and nothing is more important to us than ensuring that everyone knows that Each of our 90+ offices has its own individual identity, and each also has its own unique rewards
Locations:
INTL-Pune
Description
Review documents in workflow and assign to the team for QC2
Responsible for QC and review of study documentation for Trial Master File (TMF) quality for sponsor and/or CRO studies
Answer Q&As in project rooms and ensure they are completed within timeline
Keep study specific trackers up-to-date and communicate them to the PMs
Attend weekly/biweekly meetings with the PMs and discuss project issues and statuses
Coordinate with Clinical Document Team Leads for project related queries
Check documents in clarification and rejection status for assigned projects
Review reports for clarification and rejection monthly before the reports are sent out to the client
Keep project mappings up-to-date, coordinate with the study leads for requirement of changes to mappings
Perform internal reviews of assigned eTMFs for audit readiness
Review internal audit reports and perform corrective actions as required
Assist with User Acceptance Testing during product development and release
Work on cross functional teams including Project Management, Business Development, Client Services, Development, and IT on the implementation and management of client projects
Gather and provide feedback on features and enhancements that may be needed on an ongoing basis to Development Team
Serve as part as the Project Team on client projects
Participate and become an expert in the TMF Reference Model and stay current on regulatory changes
Become an expert in Trial Interactive features and functionality and work with Director of Clinical Operations, Project Management, and Development to recommend new features and functionalities to improve the product and reduce manual activities
Take a proactive role in learning about clients’ industry, business needs and company culture, educating the Project Team, identifying new business opportunities, and providing a high level of service
Set and fulfill client expectations
Perform other special projects or duties when required
Complete all other tasks that are deemed appropriate for your role and assigned by your manager/ supervisor
