Jobs at Alimentiv

Manage clinical site start-up activities: prepare and distribute start-up packages, track site timelines and metrics in Smartsheet/CTMS, support contract and budget negotiations, maintain site intelligence trackers, liaise with sites and internal teams (Project Management, Regulatory, Contracts/Legal), and provide project management support to ensure timely regulatory and IRB compliance.

Support site start-up activities across project management, regulatory, and contracts. Serve as primary site contact, prepare and track start-up documents, negotiate budgets/contracts within margins, maintain site intelligence trackers, update CTMS/Smartsheet, and report start-up metrics to project teams.

The TMF Associate is responsible for managing and maintaining the Trial Master File content throughout the study lifecycle, ensuring completeness, organization, and compliance with regulations while collaborating with study teams and providing training.

Provide expert, study-facing TMF oversight for complex studies and programs from start-up through close-out; ensure TMF quality, compliance, and inspection readiness using risk-based approaches and metrics; advise sponsors and stakeholders; lead audit/inspection activities; mentor TMF staff and drive process and system improvements.

The role involves leading clinical monitoring, ensuring compliance, managing teams, and engaging with sponsors while improving processes and operational excellence.