TMF Manager

at  Barinthus Biotherapeutics

The role will work closely with other members of the Quality Team to advise and oversee TMF compliance in the teams that support Barinthus Biotherapeutics’ clinical trials e.g. Clinical Operations, Statistics, Data Management, Clinical Development, Immunology Laboratory, Regulatory and Manufacturing and external vendors, in accordance with local and international quality and regulatory requirements.

Activities may differ depending on clinical trial but could include, but not be limited to the following:

• To define and develop a standardised infrastructure for Barinthus Bio’s internal TMF.
• To provide TMF management guidance and escalation across all trials, including support with CRO oversight.
• To support operational teams during escalation of issues with CROs and subsequent management of actions to rectify deficiencies.
• To provide expert knowledge on Veeva Vault Clinical and hands on assistance to the vault owner on development and implementation of workflows and processes.
• Provide training, support and guidance to the Veeva Vault Clinical users: including user set-up, troubleshooting document issues, performing QC tasks as part of a QC group and other tasks as required.
• To review existing and develop new SOPs and other processes for oversight of Barinthus Bio’s Internal TMF and CROs TMF
• To develop a standardised TMF Health and completeness review processes for Barinthus Bio’s TMFs and CROs TMF
• To develop standardised reports and dashboard metrics for Barinthus Bio’s internal TMF, assisting in creating reports for Quality Team Senior managers to deliver to Barinthus Bio’s Senior Leadership Team.
• To review TMF Plans and Indexes as SME.
• To perform regular spot checks on CRO TMF and Barinthus Bio’s internal TMF and provide status reports to the internal study teams.
• To help in the development of a data transfer process for incoming TMF imports, or cross system transfers.
• To develop other processes as required to ensure Barinthus Bio TMFs are inspection ready.

• To provide Veeva Vault Clinical TMF training to new company employees as required.
• To be the Functional Lead for TMF (acting as technical resource) and provide support and guidance when required.
• To help with decision making in relation to TMF set up and processes.
• To have oversight of TMF audit report findings and recommended actions.
• Ensuring compliance with GCP and other regulatory requirements.
• Working with the other member of the Quality Team to ensure Barinthus Bio maintains ‘Inspection Ready Status’ at all times
• To support any inspections as an SME
• To support TMF Archiving processes and systems