eTMF Specialist

A well-established CRO is seeking a Document Specialist to be based in Basel on a permanent basis. The Document Specialist will be responsible for the execution and maintenance of key documents in both our Clinical Science and Clinical Operations departments.

Job Responsibilties:

• Support the Clinical Science and Clinical Operations teams in the maintenance of the Trial Master File (TMF) on rare disease studies
• Create, implement and maintain document tracker for each study
• Retrieving, renaming and filing documents in TMF (including backlog) in accordance with GCP and SOPs & conventions
• Upkeep of the TMF Table of Contents as instructed by the study team manager
• Document formatting support for Clinical Science documents
• Managing document-related communications with external vendors (translators, printing companies, archiving)
• Maintenance of the publication library, retrieval of publications necessary to support regulatory and scientific work
• Supports the collection of essential documents required from various Sites/CRAs
• Maintenance of the document tracker supporting Clinical Trials
• Maintenance of documents filed in the paper TMF
• Provide support in scanning documents for the TMF, including QC of documents
• Supports Quality Control of the TMF on a regular basis
• Indexing of files moved to archiving
• Document formatting support for Safety documents
• Support printing and assembly of documents from the TMF for distribution to sites; including the Investigator Site File (as required)
• Provide regular support as needed
• Other activities as required

Skills and Requirements:

• Previous experience in a document specialist position where organized file structures are imposed
• Experience with clinical trial processes and documentation, including Trial Master File and knowledge of ICH GCP would be a plus
• Ability to multi-task and stay focused on priorities, strong analytical skills
• Expertise with Microsoft suite
• Team spirit and strong service orientation
• Understanding of the Industry/Clinical trial process and drug development

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.

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