TMF Configuration Consultant - UK - 0.6 FTE
Location | United Kingdom |
Discipline: | Clinical Operations |
Job type: | Contract |
Salary: | ££300-340 |
Contact name: | Harry Henson |
Contact email: | harry.henson@rbwconsulting.com |
Contact phone: | +441293364092 |
Job ref: | 27004B |
Published: | about 1 month ago |
Duration: | 12 months |
Expiry date: | 21 Apr 2024 10:59 |
Startdate: | ASAP |
I'm currently partnered with a UK based clinical-stage Biopharma who's primary focus is in the Rare Disease space, in their search for a TMF Configuration Consultant to join the UK team. The main quality this organisation are seeking is someone who has experiencing not just using and implementing Veeva Vault, but also the configuration aspect, as this will play a large part of your day to day to rule initially.
The ideal profile will be able to start this position in mid April and will be available for 0.6 FTE on a 12 month contract. The reason you need to be based in the UK, is that the organisation have a "all hands on deck" day every Wednesday in the London office, so the ideal candidate will be based in or around the London area.
Overall Responsibilities:
Veeva Vault (VV) expert and document management subject matter expert
Primary point of contact for VV and document management activities for internal and external stakeholders and partners
Ensuring consistent, high quality record management is maintained for all product and clinical trial content.
Leading / Coordinating continued Sponsor Oversight is maintained throughout each study
Documentation Responsibilities:
Support cross functional teams to ensure complete and accurate TMF/Platform product documentation across development portfolio
Lead TMF and product filing activities within the organisation with focus on quality, completeness and contemporaneous status
Review and standardise legacy filing including import and archive activities
Lead the transfer of external TMF’s and document sources into Veeva eTMF/Platform as required
Ad-hoc upload and retrieval of documents as requested by cross-functional team
Support with the documentation preparation and transfer in the event of a partnering agreement
Status and Management Responsibilities:
Completion and management of QC processes within VV to support and oversee quality document filing and to assess overall TMF Completeness, both internally and externally in aid of maintaining continued
Inspection Readiness Responsible for reporting status of all TMFs internally and externally and reporting to CST and cross functional teams
Appropriate remedial work to current eTMF’s and user training to ensure TMF Processes are followed
Escalate issues, share best practices, and leverage cross-functional operations team for issue resolution Lead development and maintenance of TMF Plans for all studies
Coordination of internal and external partners to ensure delivery of final, complete and inspection ready TMF at study close
Contribute to cross functional team discussions on document management related activities and initiatives
System Responsibilities:
Management of various systems access requests
Contribute and lead VV system improvements, periodic validation activities and software updates
Support with the improvement of all VV vaults, including eTMF, Platform and QMS.
Participate and lead interactions with VV Business Unit for the maintenance and improvement for the VV system
Forecast and oversee budgets for VV systems where appropriate
Process Responsibilities:
Follow established procedures and SOPs; seeks ways to improve and streamline processes to support document management
Establish, improve and refine document Management and VV system related SOPs and processes development
Work with internal & external teams to identify, define best practice and assist with document filing Mentoring staff to ensure awareness and consistent following of current operating procedures and best practices
Execute training sessions with team members on systems and new initiatives
Apply here and Harry Henson will be in touch to discuss your application in more detail!
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