JOB SUMMARY

Performs support tasks related to the set-up, maintenance and close out of the Trial Master File.

JOB RESPONSIBILITIES

• Process study documentation in accordance with Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and study specific TMF Plans.

• Support the set-up, maintenance, and closure of TMF repositories.

• Support documentation collection activities, including:

o Document scanning and indexing for trial using an electronic TMF

o Document filing for trials using a paper TMF

• Perform quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified

• Maintain compliance with departmental quality, performance and utilization targets

• Complete administrative tasks (e.g., status reports) as requested

• Maintain compliance with company requirements (e.g., time tracking, training)

• Participates in preparation/reconciliation of TMF documentation related to audits, inspections and shipments.

• Participates in study specific training as required.

• For Paper documents, responds promptly to each request received for a project document or project file, ensures timely and appropriate delivery to the requestor, and timely and accurate re-filing upon return. Ensures that all applicable paperwork is completed upon release and return of each project document and/or project file from the Document Control Room

• Ensures the security and compliance of all documents related to active and archived projects

• Performs other work-related duties as assigned. Occasional travel may be required (up to 10%).QUALIFICATION REQUIREMENTS (please indicate if 'preferred')

High school education, some college courses in the scientific/regulatory field preferred. Some experience in a clinical trials environment preferred. Some knowledge of applicable regulations and guidelines with respect to regulatory documents and familiarity with medical terminology preferred. Familiarity with electronic TMF system preferred. Strong verbal, written and organizational skills with a team-oriented approach. Ability to handle and prioritize multiple tasks to meet deadlines in a dynamic environment. Proficiency in Microsoft Office Suite and Adobe Acrobat.