eTMF Expert Lead
Valneva, Austria

The eTMF Expert Lead will ensure completeness, contemporariness, and correctness of TMF documentation for all clinical trials sponsored by Valneva. He/she will set up a comprehensive TMF management on Sponsor side and help study teams process TMF documentation, establish best practices, and stay inspection ready.

Responsibilities

• Adapt/write SOPs to ensure optimal (e)TMF management by Valneva
• Develop general eTMF specific performance metrics and status report/presentation template that can be used for each study.
• Develop a Valneva’s study specific TMF documents list including program specific TMF documents, and support the maintenance of this list throughout the study.
• Participate in the study kick-off meeting and support the presentation of the (e)TMF activities.
• Lead regular eTMF meetings with study team internally (Valneva) and externally (with the CRO) to ensure timely filing of quality eTMF document throughout the study duration and completeness as per the relevant study phase (set up, initiation, recruitment, close out).
• Lead the writing of the Sponsor sections of the study specific TMF plan for each study.
• As part of the TMF plan, ensure availability of a list of expected documents on study level (including the Sponsor documents), check that this list is updated at regular interval during study conduct and that a final list is available at study end.
• Ensure that study specific Valneva (e)TMF documents are reviewed and submitted for (e)TMF filing within required timelines by the study team.
• Perform regular (e)TMF checks as relevant for each stage of the study (submission, FSI, LSO, preparation for COV), this includes checks for document quality, timeliness and completeness as per Valneva SOP.
• Follow- up with CRO/relevant vendors on identified (e)TMF issues.
• Responsible for the (e)TMF archiving at end of study

Requirements

• Profound GCP knowledge and good documentation practices, as well as clinical trial documentation in particular
• Broad experience (at least 3y) of document management (e.g.: document/SOP writing (e)TMF filing, (e)TMF review and quality checks) in clinical trials
• People management experience preferred

Benefits

• Open, appreciative company culture with innovative spirit and attractive assignment.
• International surrounding with flat hierarchies.
• Good team spirit in a strong and highly motivated team.
• Wide range of benefits like flexitime, performance-related bonus, lunch vouchers, child care center (Kindergarten), company events.

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is 45.000,00 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

Job Rewards and Benefits