Document Control Specialist I
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About The Position
The Document Control Specialist I position is designed to provide essential administrative support to the Clinical Operations team within Immatics US. This role is pivotal in ensuring the effective management of Trial Master Files (TMF), both electronic and paper-based, which are critical for the compliance and success of clinical trials. The specialist will be responsible for the setup, maintenance, closure, and archival of in-house and outsourced TMFs, ensuring that all documentation is organized and accessible as per regulatory requirements. In addition to TMF management, the specialist will oversee the outsourced TMF setup and maintenance, preparing a comprehensive TMF Management Plan that outlines the processes and standards for TMF handling. The role also involves performance reviews of TMF filing and archiving, as well as providing support to ensure that the TMF is compliant with Good Clinical Practice (GCP) standards. This includes the development and maintenance of tracking tools, preparation of reports, and quality control of clinical trial documents. The position requires a proactive approach to identifying areas for improvement within the scope of work, as well as the development of standard operating procedures (SOPs), guidance documents, and training materials. The specialist must possess strong organizational skills to manage their tasks effectively and contribute to the overall efficiency of the Clinical Operations team. This role is primarily remote, requiring the individual to maintain a professional office environment that allows for privacy and quiet during work hours. The work environment should be equipped with necessary office supplies and technology to facilitate communication and productivity. The position may require occasional travel to the company’s Stafford, TX location for business purposes.
