- 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
- 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
- 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
- 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
- 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
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TMF Configuration Consultant - London, United Kingdom - RBW Consulting
Description
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:
Documentation Responsibilities:
Status and Management Responsibilities:
System Responsibilities:
Process Responsibilities:
Apply here and Harry Henson will be in touch to discuss your application in more detail
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