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Clinical Document Manager

Company Name:
BioBridges, LLC
Due to increase in volume of work, we need another hand to support the TMF. This is a 4 month contract at the client site.
The Clinical Document Manager is responsible for the structure, maintenance and control of clinical Trial Master Files (TMFs) that are required to document the conduct of clinical trials.
o Clinical Document Manager is responsible for Trial Master File (TMF) quality for sponsor and/or CRO studies and serves as the primary point of contact for TMF processes, systems and controls
o Develops and implements a TMF reference model based on industry best practices and current/future regulatory requirements
o Develops a quality control plan for TMFs and ensures all TMFs are created, maintained, monitored, QC checked, closed out and archived on a timely basis
o Plans and performs periodic quality checks of TMFs to identify filing issues and ensure compliance quality standards; implements effective corrective and preventive actions where required
o Interfaces with contract organizations to ensure TMF deliverables meet contracted requirements
o Ensures the TMF is able to fully reconstruct the conduct of a clinical study and documents are readily available for audits and inspections
QUALIFICATIONS AND BACKGROUND REQUIREMENTS
o Bachelors Degree is required
o Minimum of 6 years in the pharmaceutical, biotechnology or medical device industry with at least 3 years experience in Clinical Trial Master File management


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