Summary: Provides support to Study Manager and other study team members. This position is responsible for the appropriate collection, scan, index, quality check, file, archival and retrieval of records for the Clinical Operations’ section of the Trial Master Files (TMF) and electronic Trial Master Files (eTMF). Provides expertise in record management and archival support for Clinical Operations. Including but not limited to the safekeeping and accessibility of Clinical Operations’ Trail Master File records for all sponsored clinical studies by ensuring records are appropriately and securely filed and archived. Responsible for supporting the definition, implementation, execution and process improvement related to TMF/eTMF activities.
- Set-up Clinical Operations’ paper or electronic folders, as applicable Process Clinical Operations’ administered TMF records: scan, index, quality check and file against pre-defined quality criteria and in compliance with service levels
- Manage Clinical Operations’ administered TMF inventory trackers or eTMF reports.
- Resolve Clinical Operations’ administered TMF/eTMF -related queries or quality issues by working closely with study teams
- Ensure completion and accurateness of Clinical Operations’ administered TMF/eTMF at all times and provide advice to study teams with respect to the filing of records
- Support Clinical Operations’ administered TMF/eTMF review process by working closely with study teams
- Preform assigned TMF/eTMF review actions in a timely manner Support Clinical Operations’ preparation for a TMF/eTMF audit or inspection (i.e. inspection readiness)
- Prepare for receipt of CRO’s portion of the TMF/eTMF Process the CRO’s portion of the TMF/eTMF in a timely and controlled manner in accordance with procedures
- Archive Clinical Operations’ administered TMF/eTMF records in a timely and controlled manner in accordance with procedures
- Perform quality checks and test retrievals of Clinical Operations’ administered TMF/eTMF records from long-term, off-site archival on sponsor’s behalf; document any findings and follow to resolution or escalation in compliance with company and expertise area controlled procedures and GCP Support and train Clinical Operations’ team members on correct archival procedure of Clinical Operations’ administered TMF/eTMF records
- Continuous assessments of Clinical Operations’ record management work practices in order to maximize efficiency; communicate to management any improvement suggestions
- Other project related activities, as needed
- Competent computer skills including MS Office Suite.
- Experience working with eTMF systems is preferred
- Experience working in a regulated environment such as a CRO or pharmaceutical company is preferred.
Skills & Attributes:
- Demonstrated good communication skills (written and verbal).
- Attention to detail.
- Able to work in a fast paced environment that requires effective multi-tasking and ability to easily adapt to changing priorities.
- Ability to work in a team environment as well as independently