We are searching for a motivated Clinical Advisor to join our exceptional team at Veear Projects Inc in Rockville, MD.
Growing your career as a Full-Time Clinical Advisor is an unparalleled opportunity to develop competitive skills.
If you are strong in decision-making, attention to detail and have the right initiative for the job, then apply for the position of Clinical Advisor at Veear Projects Inc today!
Technical Requirements: - 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.
- Minimum of 3-5 years of TMF specific experience is required.
Benefits of working as a Clinical Advisor in Rockville, MD:
● Opportunity to Make a Difference
● Company offers career progression opportunities
● Advantageous package