Trial Master File Advisor

Nextonic Solutions is seeking a highly ambitious, adaptable, structured, and detail-oriented Clinical Advisor&ampnbsp to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS), Office for Policy in Clinical Research Operations (OPCRO).

Requirements:&ampnbsp

• 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.

Specific Qualifications:

• BS degree is required, MS preferred.

Job Type: Full-time