Clinical Operations Lead
Pubblicato il 17-08-2026 - Biotecnologie - Farmacia - Chimica in Parma
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/CIR)
Contribute to registry submissions and result