Clinical Systems Ops & TMF Lead

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
...