01 ott - Italia
JobLeads
In this Clinical Operations Lead role, you will guide strategic and hands-on management of global clinical development programs across Early Phase, Late Phase and RWE studies. You will align cross-functional teams within the Clinical Development Plan and mentor Clinical Project Managers. You'll oversee end-to-end operations, manage budgets and vendors, and drive risk and quality governance. This is a chance to shape programs at a financially responsible, highly collaborative biopharma group with a strong patient focus.
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- pension
- private medical insurance
- remote work options
- Lead program strategy and ensure study alignment within the program
- Contribute to Clinical Development Plan feasibility, timelines, geographic strategy, and budget
- Maintain integrated timelines and milestones including go/no-go decisions
- Serve as primary Clinical Operations interface for cross-functional teams
- Oversee end-to-end Clinical Operations activities
- Support CPMs on operational decisions and compliance (ICH-GCP, SOPs)
- Contribute to study design and feasibility assessments (CPAC)
- 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
- Accountable for program-level budget with planning, forecasting, and variance analysis
- Participate in governance bodies and present updates/risks
- Provide functional supervision and escalation support to CPMs
- Coach and develop CPMs (IDPs, objectives)
- Drive risk mitigation, CAPAs, and inspection readiness
- Support regulatory documentation (eCTD, CSR/CIR) and registry submissions
- Support SOPs and continuous improvement initiatives
- Ensure compliance with required training
- Advanced degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline
- Significant experie
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