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(Loading More Opportunities)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.
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 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