Beschreibung
On behalf of a major Pharma client, Harvey Nash is urgently looking for a
Trial Document Specialist (from study set-up to archiving) for a 12 months + role in Basel (Switzerland).
Job purpose:
As "Trial Document Specialist" you will assist with the life cycle management and associated processes (from study set up to archiving) of Trial Master Files for clinical trials conducted within the CS & I department, according to ICH and internal guidance.
Core responsibilities applicable for studies following eTMF procedure:
Supports CTLs in the set-up of an electronic Trial Master File (eTMF) process for assigned studies, eg: discuss & agree with CTL on electronic delivery plan of TMF documents (timing of document availability, delivery routes/through WDCS/, scanning activities, timing & content of quality checks Work with mDoc and MLM group to ensure CRA/CRO is trained on WDCS or other agreed process for electronic TMF document delivery Support CTLs in the maintenance of trial documentation: Work with mDoc and/or CRAs/CROs to resolve issues identified during mDoc WDCS upload or other electronic upload into CREDI, and other tasks Act as subject matter expert and/or superuser for WDCS and other TMF IT tools, eg eTRAC Set-up of electronic TMF Table of Content at study start and update as appropriate during study in agreement with CTL Set-up of paper TMF folder structure & receipt of paper TMF documents from CRA/site at defined intervals during the trial for those originals still required to be on file, arrange for archiving of paper TMF at study end Participate in the creation & harmonization of templates/guidances, eg trial document delivery plan template, document tracking tools, training materials, TMF QC guidances, assist in maintaining a global tracking of trial master file locations (during study and upon archiving), act as back-up or provide support to other Trial Document Specialists globally Support CTL in reviewing eTMF content, help with generating study specific documents, eg RIS & FPP checklists, drug shipment documentation, Vendor Activity Worksheets, CSR appendices, and other tasks. Key performance indicators:
Timely assistance to the CTL in the set-up and maintenance of an electronic TMF incl. maintenance of paper files for those originals still required to be on file Assistance to the CTL to maintain TMFs in an inspection-ready condition Feedback of external & internal customers. Requirements and skills/background:
Associates Degree (for graduates) or equivalent work experience Good knowledge of regulatory requirements & Best Practices pertaining to trial document management and archiving of clinical trial documentation Some knowledge of clinical trial design, execution and operations would be beneficial Good knowledge of GCP Good organizational and interpersonal skills Ability to work independently and manage multiple priorities, PC literacy fluent English. Project details:
Start: ASAP for 12 to 13 months no remote work option, normal working time is 40 working hours/5 days in the Basel office hourly rate, best offers considered for interviews. Interested and available to start immediately this challenging role in Basel? Please send your detailed English CV (MS Word file, references welcome) or call me. Please apply only if you offer relevant experience in electronic Trial Master File or Trial Document Management - thank you!
Harvey Nash AG will support you with relocation tips and take care of all permit/payroll/admin related details.
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