eTMF Lead

eTMF Lead

Location: Vienna, Austria

– Can also be based in Sweden, the United Kingdom, or France

Engagement: Full Time Position

Flexibility: Hybrid role, if in Vienna 5 days a month in offices. Can vary to suit your location

The Company:

A medium sized pharmaceutical company with 3 commercialised products and much more coming in the pipeline, the company has focused their efforts on providing products first-of-it’s-kind vaccines to address previously unmet medical needs. Every member of the team is driven by the knowledge their efforts are providing highly needed solutions for the patients. As an organisation they value internal collaboration and enabling their employees to have an impact on the company.

The Role:

As eTMF lead you will be a crucial part of this sub-group, essentially leading the creation of the group! This will be give you high autonomy, and will be perfectly suited to someone with extensive experience handling the eTMF documentation. Working closely with C-Suite and VP members of the company you will be a vital part of this organisation, and the group’s growth

Responsibilities:

• Revise/modify Standard Operating Procedures (SOPs) to ensure The Company’s effective management of the electronic Trial Master File (eTMF).
• Create standardized performance metrics and a status report/presentation template specific to eTMF for universal use across all studies.
• Develop a comprehensive list of The Company’s study-specific TMF documents, including program-specific items, and assist in maintaining this list throughout the study.
• Participate in the study kick-off meeting and provide support for presenting eTMF-related activities.
• Lead regular eTMF meetings with both internal (The Company) and external (CRO) study teams to ensure timely and high-quality filing of eTMF documents throughout each study phase (setup, initiation, recruitment, close-out, etc.).
• Take the lead in composing the Sponsor sections of the TMF plan tailored to each study.
• Ensure that The Company’s study-specific eTMF documents are reviewed and submitted for eTMF filing in compliance with specified timelines set by the study team.
• Conduct periodic eTMF checks relevant to each stage of the study (submission, FSI, LSO, preparation for COV), encompassing assessments of document quality, timeliness, and completeness following The Company’s SOPs.
• Work with and direct the CRO’s and relevant vendors to address identified eTMF issues.

Ideal Experience you’ll bring to the role:

• Demonstrated experienced creating and setting up SOP’s
• Ideally experienced working with CRO’s (or working with pharma/biotech companies from a CRO)
• In-depth GCP Knowledge and documentation practises (especially Clinical Trial Documentation)
• Ideally 3 years + in managing documentation including but not limited to; SOP writing,TMF review,TMF filing, quality checks, etc)
  • Able to communicate clearly and effectively with senior member of the company

Want to find out more? Then click apply and I’d be glad to share additional information.