- Experience Level
- Experienced (non-manager)
Covance is looking for an eTMF Spcialist to work 100% dedicated to one of our clients which is an Italian leading pharmaceutical company.
This position can be office based in Parma or home based in Milan with some commute to Parma.
Check out the role responsibilities and requirements below:
Job Responsibilities :
- Perform an ongoing quality control of the eTMF (Data Management/Statistical section). Ensure its inspection readiness i.e. completeness and compliance with the relevant requirements from study start-up until archiving.
- Perform review of the eTMF management plans and provide relevant input.
- Escalate to the relevant functions any limiting factors and non-compliance related to the eTMF quality and provide comprehensive guidance on issue resolution.
- Monitor the eTMF quality issues and follow up with the relevant functions (internally / CRO) until their resolution.
- To train and provide practical support to eTMF users (CROs) on the use of the system.
- Provide regular eTMF process guidance on the eTMF related requirements according to the applicable SOPs, WIs, guidelines, eTMF management plan.
- Contribute to the revisions of the eTMF process and system enhancements.
- Archiving of study SAS datasets in the Company repository
- Provide support by eTMF related audit or inspections.
- Bachelor's degree or equivalent, preferably in life science, clinical re- search, or related discipline.
Skills and Requirements:
- Comprehensive practical knowledge of TMF processes, related standards (e.g. DIA Reference Model) and its quality control.
- Thorough understanding of ICH-GCP quality standards and other relevant regulations
- Minimum 5 years of clinical trial experience in the pharmaceutical industry, with a minimum of 3 years' experience with the eTMF.
- Proficiency with Microsoft Office applications as well as practical experience with the electronic Trial Master File.
- Basic knowledge of SAS System is a plus.
- Fluent knowledge of spoken and written English.
- Ability to work on multiple studies simultaneously.
- Very good self-organization, time management skills, independent and structured way of working.