Love TMFs but tired of Filing? We have an exciting opportunity for a Trial Master File Study Owner to work with one of our Biotech clients who focus on developing and commercialising new therapies for rare disease patients.
This a UK home based position, occasional travel into central London will be required.
As TMF Study Owner you will ensure that the clinical trial documentation must be consistent with the Trial Master File (TMF) specifications, submission/inspection readiness criteria and comply with applicable SOPs and other requirements. The TMF Study Owner is the subject matter expert to and single point of contact for the Project Manager and Study Team to ensure a complete and accurate TMF through documentation quality and consistency across clinical trials and programs.
We are looking for individuals who have:
- Contribute to the development and assist with the implementation of the TMF specifications, such as process and system changes.
- Lead the set-up and maintenance of the TMF Study Specific Document List (SSDL) and monitor completeness and quality of TMF content for all assigned clinical trials until study close out.
- Ensure documentation flow is within projected timelines and determine course of actions to prevent and remediate delays/slippages.
- Ensure consistent use of standardised processes and technologies across clinical trials and programs.
- Serve as point of contact for internal and external audits of study TMF-related queries.
- Actively identify continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis.
- Provide support and guidance to the Study Teams to drive performance against metric targets.
- Apply lessons learned to continuous improvement of documentation management practices across study teams.
- Ensure complete TMF is in place at time of study close/submission.
- Previous direct TMF working experience, including Clinical/TMF Operational oversight.
- Extensive experience in Clinical Documentation Management, with a thorough understanding of the clinical trial project lifecycle and document management.
- Experience with Veeva eTMF system is essential.
- Experience supporting regulatory submissions and inspections.
- Intermediate MS Word, Excel, PowerPoint and Outlook. Experience of using Skype and other web based telephone conference services.
- Ability to establish and maintain cooperative relationships, and work effectively with all levels of personnel on TMF management issues across multidisciplinary teams globally.
- Ability to remain calm/focused in high-stress situations and maintain a high level of accuracy and attention to detail in fast-paced environment with shifting priorities.
- Be flexible, pro-active, self-motivated and able to work independently with minimal supervision. Be able to prioritise and seek input where necessary.
- Excellent verbal and written communication skills, combined with outstanding listening skills.
- Have a flexible working approach (sometimes outside of normal UK working hours).
- A sound knowledge of working across international boundaries and cultures.