This position is no longer open for applications

• The Clinical Information Specialist will support the day to day operations of the clinical archive and ongoing migration activities. 
• This role will be the primary liaison with study teams responsible for planning, implementation, execution and compliance of archiving plans for clinical studies including archiving for multiple clinical vendors in order to maintain inspection readiness. 
• Ensure quality of archived TMFs throughout defined retention period. 
• Work with project teams and partners to resolve any issues identified with the TMFs submitted for archiving. 
• Support integration and migration of TMF content from partnerships and acquisitions.

Job Duties & Responsibilities

• Support day to day management of the archive, archive processes, and related continuous improvement efforts.
• Provide subject matter expertise to study teams to ensure archiving arrangements are outlined appropriately in each study TMF plan.
• Provide project management of archive initiatives.
• Work closely with CPL and CTM to execute TMF closeout processes.
• Provide quality oversight of partner migrations to final archive system(s).
• Provide subject matter expertise in integration of partnered or acquired clinical information including transfer of TMFs in compliance with applicable regulations and best practices.
• Maintain historical data including tracking records retention periods for archived studies.
• May attend cross functional meetings.

Skills: Essential Qualifications

• 2 years TMF or information records management experience preferably in clinical research environment.
• Demonstrated critical thinking capabilities with forward looking perspective and comfort with ambiguity.
• Strong verbal, written, and organizational skills with a team-oriented approach.
• Ability to handle multiple tasks to meet deadlines in a dynamic environment.
• Experience in MS Office software including: Word, Excel, Outlook, and PowerPoint. 
• Strong eTMF experience a plus, particularly in PhlexEview and/or Veeva systems.
• Experience with large scale document/data migrations a plus. 

Preferred Qualifications

Experience working in clinical research / medical environment, including exposure to medical or regulatory records highly desired.

Education: Bachelor's degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development is desirable.