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) Hybrid working (remote + 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
Cultural fit: 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
#J-18808-Ljbffr
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) Hybrid working (remote + 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
Cultural fit: 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
#J-18808-Ljbffr
Clinical Systems Ops & TMF Lead Arbeitgeber: BioTalent Ltd
Unser globaler Kunde bietet eine herausragende Arbeitsumgebung für Consultants im Bereich Med & Patient Affairs, die auf der Suche nach einer flexiblen und sinnstiftenden Tätigkeit sind. Mit einem vollständig remote Arbeitsmodell und der Möglichkeit, 2 bis 2,5 Tage pro Woche zu arbeiten, fördert das Unternehmen eine ausgewogene Work-Life-Balance und unterstützt die persönliche sowie berufliche Weiterentwicklung durch strategische Projekte und Schulungsinitiativen. Die Unternehmenskultur ist geprägt von Zusammenarbeit und Innovation, was es den Mitarbeitern ermöglicht, aktiv an der Gestaltung von medizinischen und patientenorientierten Strategien mitzuwirken.
