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Clinical Document Specialist I

This position reports to the Clinical Document Team Manager. The Clinical Document Specialist I is responsible for first level QC of the eTMF. The Clinical Document Specialist I ensures that all QC work is complete and accurate and delivered in a timely manner to the Clinical Document Specialist III or Clinical Document Team Lead.

The Clinical Document Specialist I will also work on special projects as assigned by the Clinical Document Team Lead and/or the Clinical Document Team Manager.


  • 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 Project Managers
  • Attend weekly/biweekly meetings with the Project Managers 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
  • Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor

Required Qualifications, Skills and Experience:

  • 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)
  • Minimum High School Diploma or equivalent
  • Minimum of 1 year of experience in the Life Sciences industry
  • Experience with essential documents and other study documentation

Desired Skills and Experience:

  • Bachelor’s Degree from a 4-year college or equivalent
  • Previous employment in Pharmaceutical, CRO, Medical Device or Investigative Site
  • Experience with essential documents and other study documentation
  • Able to multitask in a fast-paced environment
  • Work well with people from a variety of different backgrounds and cultures
  • Build relationships with clients and co-workers
  • Can work independently and as part of a team
  • Take active measures to solve problems and commit to a high level of service
pune, MH, IN