A leading global pharmaceutical company has a new vacancy for a eTMF Specialist to join their expanding Zurich team. The company has a superb pipeline and operates in over 90 countries around the world. This eTMF Specialist job will support the development delivery functions with tasks related to the eTMF quality control and maintenance. Provide guidance on the eTMF process and practical support on how to use the system. Follow up with the internal and vendor functions on the eTMF quality issues until their resolution.
- Perform an ongoing quality control of the eTMF. Ensure its inspection readiness i.e. completeness and compliance with the relevant requirements from study start-up until archiving.
- 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 (sponsor / vendor) until their resolution.
- Provide regular eTMF process guidance on the eTMF related requirements according to the applicable SOPs, WIs, guidelines, eTMF management plan. Provide practical support to eTMF users on the use of the system.
- Contribute to the revisions of the eTMF process and system enhancements.
- Perform review of the eTMF management plans and provide relevant input.
- Arrange secure shipments of wet-ink documents.
- Provide support by eTMF related audit or inspections.
Skills and Requirements:
- Bachelor's degree or equivalent, preferably in life science, clinical re- search, or related discipline.
- 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 or university hospital, with a minimum of 3 years' experience with the eTMF.
- IT literacy, proficiency with Microsoft Office applications as well as practical experience with the electronic Trial Master File.
- 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.
- Ability to work within a team in a matrix organization.
- Excellent problem-solving skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Andrea Rotmistrovsky on +44 203 854 0675 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
£0.00 - £60000.00 per annum
ProClinical is advertising a vacancy for a Biostatistical Programming Manager
ProClinical is advertising a vacancy for an Associate Manager, Business Development
€0.00 - €150000.00 per annum
ProClinical is advertising a vacancy for a Head of Research and Development Quality
An international health consulting company is seeking applicants for an RA Specialist vacancy
San Mateo, California
ProClinical is advertising a vacancy for an Administrative Assistant
ProClinical is advertising a vacancy for an Operations Regulatory CMC Analyst
ProClinical is advertising a vacancy for a Drug Safety Manager
ProClinical is advertising a vacancy for a Regulatory Affairs Manager
ProClinical is advertising a vacancy for a Quality Compliance Specialist III position
ProClinical is advertising a vacancy for a Quality Assurance Specialist III position
ProClinical is advertising a vacancy for a Brand Insights Manager vacancy