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The Trial Master File (TMF) Specialist will manage and oversee TMF operations, ensuring eTMFs are inspection ready. Responsibilities include process improvement for clinical documents, reviewing TMF plans, performing quality checks, overseeing QC reviews, and participating in study team meetings. The role emphasizes compliance with regulatory standards and contributing to metrics and KPIs for inspection readiness.

The Biomarker Operations Senior Associate will coordinate biomarker operations activities, manage laboratory setup, oversee sample management, and collaborate with Translational Sciences and Clinical Operations teams to support clinical trials. They will ensure proper data transfer and reconciliation of biomarker data and establish processes for consistency across trials.

The Head of Compliance & Ethics will strategize and lead the compliance and ethics program, ensuring adherence to legal and ethical standards across corporate activities, particularly in clinical development and commercial operations. This role involves embedding compliance principles in company operations, conducting risk assessments, leading training programs, and managing compliance investigations.