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- Provide project management of day-to-day DAIDS TMF activities including but not limited to coordinating and leading meetings, and discussions regarding all aspects of trial master files.
- Serve as the primary reviewer of TMF deliverables including but not limited to standard TMF reports, TMF messages, and TMF documents in electronic systems.
- Manage and design TMF related trainings for DAIDS and collaborators and present proposals/materials to the federal client for approval prior to implementation.
- Coordinate and communicate to provide support and guidance to various functional areas supporting DAIDSTMFs.
- Provide support of DAIDS TMF operations during TMF implementation, audits, and/or regulatory inspections.
- Ensure TMF's are "inspection ready at all times and TMF documents are filed contemporaneously.
- Monitor and identify trends, communicate issues, and recommend policy and procedural changes to improve operations to the federal client prior to implementation.
- Represent DAIDS on working groups and committees to communicate information regarding TMF policies, procedures, and requirements.
- Provide guidance, consultation and expert advice on regulations, policies and procedures to DAIDS staff and collaborators.
- Establish quality assurance standards and metrics for TMF policies and procedures.
- Ensure DAIDS compliance with all regulations, policies and procedures related TMFs.
- Participate in working groups and team meetings, as required.
- Develop SOPs as required to ensure oversight of the DAIDS TMF process.
- BS degree is required, MS preferred.
- Minimum of 3-5 years of TMF specific experience is required.
Clinical Advisor - Rockville, United States - Veear Projects Inc
