CTA/eTMF specialist
This vacancy has now expired. Please see similar roles below...
A leading global pharmaceutical company has a new vacancy for a eTMF Specialist to join their expanding Basel 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.
Job Responsibilities:
- 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.
To Apply:
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.
#LI-AR1
Related jobs
Up to US$27 per hour + Highly Competitive Salary
Philadelphia, USA
Proclinical Staffing is seeking a Cell Manufacturing Associate to join a cutting-edge cell and gene therapy company.
Highly Competitive Salary
Rockville, USA
Proclinical is seeking a dedicated and innovative QC Microbiologist with a focus on endotoxin detection methods. This is a contract position located in Rockville, MD.
Highly Competitive Salary
Cambridge, USA
Proclinical is seeking a dedicated Talent Acquisitions Coordinator. This is a contract position located in Cambridge, MA.
Highly Competitive Salary
Wilmington, USA
Proclinical is seeking a dedicated Senior Quality Specialist to provide leadership and oversight on GMP operations related to clinical manufacturing.
US$17.00 - US$20.00 per hour + Highly Competitive Salary
Joliet, USA
Proclinical is seeking a dedicated Field Specimen Processor. This is a contract position located in Joliet, IL.
Highly Competitive Salary
Boston, USA
Proclinical is seeking a strategic regulatory leader to join a renowned biotech. This is a permanent position located in Boston, MA.
Highly Competitive
City of London, England
Proclinical is looking for a Regulatory Specialist for a remote position
Highly Competitive
Hampshire, England
Proclinical are seeking a dedicated professional for a Regulatory Associate position
Highly Competitive
Burgdorf, Schweiz
Proclinical are seeking a versatile IT Solution Engineer with a focus on data management for a position in Switzerland.
Highly Competitive
Milan, Italy
Proclinical are working with an exclusive partner for a Regional Sales Manager role based in Italy.