Clinical Operations Lead

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7d2oc3

This is what you will do
An experienced Clinical Operations Lead with a strong background in global drug development, capable of providing strategic and operational leadership across complex clinical development programs. The Clinical Operations Lead (COL) ensures the integration and continuity of Clinical Operations activities across Early Phase, Late Phase and Real‑World Evidence (RWE) studies, acting as the operational representative within the Clinical Development Plan (CDP) team and as functional leader of Clinical Project Managers (CPMs).

You will be responsible for
Program Leadership & Strategy
- Ensure alignment and integration of all studies within the program
- Contribute to the Clinical Development Plan (feasibility, timelines, geographic strategy, budget)
- Maintain overall operational oversight, integrated timelines, and key milestones (incl. go/no‑go)
- Act as primary Clinical Operations interface for cross‑functional teams

Clinical Operations Oversight
- Oversee end‑to‑end Clinical Operations activities
- Support CPMs on operational decisions and compliance (ICH‑GCP,



SOPs)
- Contribute to study design, CPAC preparation, and feasibility
- Ensure consistency across studies within the program
- Define and oversee vendor/CRO strategies
- Support RFPs, evaluations, and Bid Defense Meetings
- Manage escalations and vendor governance

Budget Oversight
- Support planning, forecasting, and variance analysis
- Align with CPMs and Finance

Governance & Stakeholder Management
- Participate in governance bodies (CPRF, PRM, XRC)
- Present program updates and risks
- Facilitate cross‑functional alignment and decision‑making

Functional Leadership of CPMs
- Provide functional supervision and escalation support
- Coach and support development (feedback, IDPs, objectives)
- Drive risk mitigation, CAPAs, and inspection readiness
- Promote quality and proactive risk management

Clinical Documentation & Regulatory Support
- Support regulatory documentation (eCTD, CSR/CI

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7d2oc3