Clinical Document Specialist

Hobson Prior are currently seeking for a Clinical Document Specialist to join a brilliant biopharmaceutical establishment on a permanent basis located in Basel. Our client is focused on offering novelty solutions for rare illnesses.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will be responsible for handling papers linked to communications with suppliers on an eternal basis such as translators, etc., when needed.
• When needed, you will assist the study team with TMF planning for inspections and audits, as well as provide support throughout audits and inspections.
• To warrant TMF accomplishment, constancy, and good quality rendering to the suitable processes and regulations, you will conduct periodic QC of the TMF.
• You will partake in the improvement and development of TMF procedures at the company.
• Guarantee follow up with the paper owners/study team on matters escalated throughout the QC procedure until resolution.
• The ideal candidate will assist the clinical study teams in the upkeep of the TMF, both electronically and on paper.
• Conduct final TMF QC and final TMF transfer from CRO if appropriate, as well as assist in the filing of TMF at the end of the study.
• Any other assigned duties.

Requirements:

• Educated to a degree level in a pertinent discipline or prior experience with clinical study documentation / TMF management.
• At least 1-2 years of experience in a documentation specialist role or corresponding where coordinated archive structure was executed.
• Know-how of ICH/GCP and any other regulatory needs suitable for clinical study documentation.
• Familiarity with operating in a clinical drug development environment such as a pharmaceutical or contract research organisation.
• Comprehension of the processes affiliated with the performance of clinical trials.
• Computer literacy in eTMF systems such as Veeva, PhlexTMF, etc., and/or electronic document management systems.
• Fluency in the English language with communication skills both verbally and written.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.