TransPerfect

Clinical Document Specialist- II

ID
2016-7827
Category
Other
IN-Pune

Responsibilities

  • 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
  • Provide mentoring to the CDS I role as needed
  • Provide feedback to senior level Document Specialists and management as needed
  • 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

Qualifications

  • Minimum Bachelor’s Degree from a 4-year college or equivalent
  • Knowledge of clinical development phases and processes including GCP and ICH regulations
  • Superior written and spoken communication skills in English
  • Proficiency in Microsoft Office (Word, Excel, Outlook), and knowledge of eClinical technologies
  • Proficiency in Document Management (Adobe professional, knowledge of Scanning, indexing, using ISI Tools and Capture Perfect)

Overview

TransPerfect was founded in 1992 with the following mission: to provide the highest quality language services to leading businesses worldwide. With no external financing, the TransPerfect family of companies grew from its humble beginnings as a two-person company operating in an NYU business school dorm room into the world's third-largest translation and software localization firm and one of the fastest-growing privately held companies in the United States. With a network of over 5,000 language specialists and over 4000 full-time employees in over 90 locations across 6 continents, we're continuously ready to meet our clients' needs, around the clock and around the world. 

For over 20 years, TransPerfect has assisted life sciences companies with global, regional, and country-level product launches. Offering multiple services and solutions customized to meet the needs of each brand, TransPerfect has helped the world’s leading pharmaceutical, biotechnology, and medical device companies successfully launch products throughout the world.

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