Clinical System Manager

BioTalent are collaborating with a well regarded Biopharma company to bring on a Clinical Systems professional for a 12 month contract. You will need to be able to hit the ground running and be experienced in ensuring an inspection ready TMF. Offer: 1) 12 month duration (anticipated September start) 2) Full time contract 2) Remote working + 1x office day in Basel You will be expected to: Lead TMF operations across clinical studies, ensuring compliance with ICH/GCP and regulatory standards Manage study setup, system administration, and user onboarding in a GxP clinical operations system Drive TMF plan and index development, ensuring alignment with study strategy Monitor eTMF quality, completeness, and inspection readiness using KPIs and risk-based reviews Act as a key point of contact for study teams on TMF processes, training, and best practices Support audits/inspections and TMF archival activities Key Requirements 2–3+ years’ experience in TMF management / clinical documentation Strong knowledge of ICH/GCP and clinical trial processes Hands-on experience with eTMF systems (Veeva Vault preferred) Background in pharma/CRO clinical development environments Excellent communication skills and proactive, detail-oriented mindset Organised, collaborative professional with strong analytical skills and a passion for clinical quality, compliance, and continuous improvement. If this looks interesting to you please be in contact with dominic.pritchard@biotalent.ch
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