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Clinical Operations LeadChiesi • Ascoli Piceno, Italy
Clinical Operations Lead

Clinical Operations Lead

Chiesi • Ascoli Piceno, Italy
2 giorni fa
Descrizione dell’offerta di lavoro

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 experience in Clinical Operations in pharma/biotech or CRO
  • Proven experience managing global clinical development programs across Early Phase, Late Phase and RWE
  • Strong understanding of CDPs and clinical development processes
  • Experience coordinating cross-functional teams and acting as key interface between Clinical Operations and other functions
  • Solid knowledge of ICH-GCP guidelines and regulatory requirements
  • Experience in CRO selection, oversight, and vendor management
  • Strong project/program management skills with timelines, milestones, risk management, and budget xysqume oversight
  • Experience managing complex integrated project plans and development timelines
  • Proven ability to provide strategic and operational guidance in protocol development and study planning
  • Experience preparing clinical documentation for regulatory submissions (eCTD components)
  • Past experience with functional leadership or matrix management of CPMs
  • Strong stakeholder management and presentation skills
  • Excellent communication, analytical, and problem-solving abilities
  • Ability to work in a global, matrixed, multidisciplinary organization
  • Fluency in English (written and spoken)
  • strong communication
  • influencing and presentation skills
  • leadership and mentoring
  • ICH-GCP
  • CDP planning

Clinical Operations Lead • ascoli piceno, marche, it


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Clinical Operations Lead • Ascoli Piceno, Italy

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