Clinical Data Specialist

工作内容

The Clinical Document Management Specialist will act as a compliance expert in Document Lifecycle and Classification. Develop and maintain document lifecycles and content classification in order to facilitate document review and approval according to characteristics such as security level, function and metadata. This position will also support Clinical Trial/Project Managers on base of study needs.

Document Management Support:
• Be responsible for electronic Trial Master File (eTMF)/essential documents Quality Control and quality review process.
• Act as a compliance expert in Document Lifecycle and Classification.
• Develop and maintain document lifecycles and content classification in order to facilitate document review and approval according to characteristics such as security level, function and metadata.
• Is an eTMF Core team active member. Consult with end users regarding document management requirements and follow up on agreed action plan.

Study Team Support:
• Support Clinical Trial/Project Managers to ensure that key project information related to project milestones, team members, training records and electronic Trial Master File is up to date. Initiate and coordinate archiving of studies.
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner