Job Description
Description
The Trial Master File (TMF) Manager ensures a complete and accurate TMF through documentation quality and consistency across clinical trials and programs. The TMF Manager is accountable to the study teams, as well as to the information management group, for global clinical TMF responsibilities on the sponsor-side. The TMF Manager provides crucial TMF quality support to the study team and is expected to establish a proactive quality-focused partner-relationship with the study team.
Responsibilities:
Contribute to the development and assistance with the implementation of the TMF specifications, such as process and system changes and implementation.
Lead the set-up of the sponsor TMF study specific document list and monitor completeness and quality of sponsor TMF content for all assigned clinical trials until study close out.
Ensure documentation flow is within projected timelines and determine course of actions to prevent and remediate delays/slippages.
Ensure consistent use of standardized processes and technologies across clinical trials and programs. Determine and review study-specific TMF specifications to ensure quality and standardization is established per program and kept up to date as programs/protocols progress.
Maintain study specified document lists at the study, country, and site levels by collaborating with all relevant functional lines (e.g. data management, regulatory) to ensure documentation is in place for the study and all versions/instances are filed in a timely fashion.
Support the preparation of appropriate audit and inspection responses.
Management of contractors and consultants and document management group.
Preferred Additional Skills:
5-7 years of experience preferred
Bachelor's degree preferred
Experience in management of clinical study records and documentation.
Knowledge of ICH/GCP documentation requirements.
High attention to detail
Excellent organizational skills
Strong written and verbal communication skills
Knowledge of MS Office
Experience with the following application types: electronic documentation management systems, web-based data management systems, and database utilization
Able to work independently, prioritize, and execute next steps
Able to demonstrate a flexible, proactive, diligent, and self-motivated approach to work
Clinical documentation management experience in order to have a thorough understanding of the processes associated with the conduct of clinical trials and document management operations
Comments for Suppliers: Potential occasional need to travel onsite after pandemic restrictions lifted
Company Description
Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations. Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S. Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.