Clinical Systems Manager
BioTalent
European Union
Freelance
Full-time
Remote
Intermediate
posted 21 days ago
Vacancies Summary
Join a reputable Biopharma company as a Clinical Systems Manager for a 12-month contract. This remote role requires expertise in maintaining an inspection-ready TMF and ensuring compliance with regulatory standards.
BioTalent is partnering with a respected Biopharma company to recruit a Clinical Systems professional for a 12-month contract starting in September. This full-time position allows for remote work within the EU.
The Role
You will be responsible for leading TMF operations across clinical studies, ensuring compliance with ICH/GCP and regulatory standards. Your day-to-day activities will include managing study setup, system administration, and user onboarding in a GxP clinical operations system.
Responsibilities
- 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.
Requirements
- 2–3+ years of 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 a proactive, detail-oriented mindset.
Nice to Have
- Organised, collaborative professional with strong analytical skills and a passion for clinical quality, compliance, and continuous improvement.
If you find this opportunity appealing, please reach out to dominic.pritchard@biotalent.ch.
Required skills
Google Cloud Platform (GCP)
Strategy
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