Senior Document Manager, Clinical Development Operations
- Victoria, BC, Canada
- Department: Clinical Operations
Aurinia is a clinical stage biopharmaceutical company focused on developing and commercializing therapies in disease areas of high unmet medical need. We are currently developing voclosporin, an investigational drug, for the treatment of Lupus Nephritis (LN) and focal segmental glomerulosclerosis (FSGS). Additionally, we are advancing voclosporin ophthalmic solution (VOS), a topical formulation, for the treatment of dry eye syndrome (DES).
The Senior Document Manager is responsible for oversight, management and support of the Trial Master File, including start-up, ongoing quality and completeness reviews, and close-out activities as well as providing system support and monitoring of Key Performance Indicators (KPIs). This individual oversees the CRO and third-party clinical vendors on TMF activities and supports the internal clinical trial team members to ensure quality deliverables through meetings, running metrics, trending issues and a variety of other responsibilities associated with the TMF.
- Coordinate and oversee the management of the Trial Master File for assigned studies
- Initiate, oversee, and / or contribute to start-up activities that support TMF management, including development and / or review of TMF study plans and / or documents
- Oversee and manage the overall quality and completeness of the TMF through:
- Participation in TMF Records review.
- Oversight and management of TMF Quality Completeness review, including generation of findings, identifying gaps, trends and query resolutions
- Uploading of documents into the eTMF
- Oversee and support migration and/or manage activities for archival of TMF in appropriate systems / platforms
- Analyze trends, gaps and metrics to ensure proper escalation
- Engage in system reviews, implementations, migrations, upgrades and UAT
- Contribute to the development and implementation of processes that support TMF management and inspection readiness
- Contribute to, develop and update related and relevant SOPs
- Participate in and contribute to project team and study meetings (internal and external)
- Ensure work is performed in compliance with GCP requirements
- Represent the company and present at Meetings (internal and external)
- Other such duties as may be determined
- Minimum of 5 years of experience managing TMF activities to support multiple global studies
- Experience in managing paper and electronic TMFs
- Experience with DIA TMF Reference Model
- Knowledge of the drug development process and GCP requirements
- Working knowledge of international regulatory record requirements and ethics requirements
- Experience in managing TMF documents during regulatory inspections is an asset
- Experience working with and developing processes that support a variety of electronic TMF systems and ability to learn new technologies
- Strong computer skills including Outlook, MS PowerPoint, MSWord and MS Excel
- Ability to work well independently as well as a member of multiple, collaborative, integrated teams.
- Excellent organizational and time management skills
- Ability to multi-task and manage several projects in parallel while paying attention to detail
- Strong critical thinking skills and ability to contribute creative yet practical solutions to problems
- Bachelor’s degree preferred.
- Ability to travel (including internationally) and work across cultures.
All candidate information will be kept confidential according to EEO guidelines.