- Manages the the review, filing, archival, tracking and retrieval processes for completed TMF related documents stored on or off site.
- Maintains integrity of TMF storage area (room access, closure, etc.) and orchestrate off-site storage processes
- Manages document review requests and resolve documentation issues
- Creates and maintain database of all documents, paper or electronic, including exact location
- Leads the clinical document control efforts in preparing for and participating in an audit and/or regulatory inspection.
- Supports the implementation and management of electronic and paper Clinical Trial/TMF Documentation
- Supports the management of Clinical Study Records life cycle, including retention and disposition of records and associated audit trails in accordance with best business practices, applicable regulations and corporate policies and procedures
- Supports the creation and execution of clinical documentation TMF training
- Serves as a liaison for internal/external customers
- Supports R&D Clinical Compliance in providing measures of performance such as Metrics and KPI for continuous improvement
- Supports the transition of proprietary information for acquisitions, divestitures and licensing of compounds related to trial master file records
- Supports other R&D Compliance projects as needed
- Supports the maintenance of TMF Index
Required Knowledge, Skills, and Abilities
- Experience in Trial Master File requirements and set-up
- Knowledge of DIA filing structure
- Knowledge of global regulatory requirements and ICH/GCP guidelines
- Working knowledge with electronic document management systems and document archival systems (eTMF)
- Demonstrated ability to work independently and in a team environment
- Strong organizational abilities, action oriented and strong communication skills
- Able to carry out responsibilities with minimal to no supervision
- Knowledge of document management processes and procedures, electronic documentation systems, data retrieval, and electronic file formats
- Ability to demonstrate initiative.
- Ability to plan and organize work in an efficient manner, and work well under time constraints.
Required/Preferred Education and Licenses
- Bachelor Degree or minimum of 3 years directly related experience Clinical Trials, TMF and clinical systems and process
- Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Visio, Outlook)
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
- Occasional public contact requiring appropriate business apparel.