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Job Details

Document Specialist

Company: ProClinical Ltd
Location: Zürich
Reference: CR.VP.19019
Closing Date: 22 Aug 18
Type: Contract
Salary (£): 80,000 - 100,000
Benefits:

Job Summary:

ProClinical is seeking a Document Specialist to be based in Zurich on a 6-month contract basis. This role 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 Responsibilties: * Perform an ongoing quality control of the eTMF. ...

Requirements:

ProClinical is seeking a Document Specialist to be based in Zurich on a 6-month contract basis. This role 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 Responsibilties:

* 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 Valaince Penteng on +44 203 8460 643 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.

Apply for this job: Document Specialist

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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