Clinical Operations Lead

Chiesi; Rovigo; Ibrido; EUR 90.000 - 140.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Remote work options

Descrizione del lavoro

Chiesi is seeking a Clinical Operations Lead to 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 will oversee end-to-end operations, manage budgets and vendors, and drive risk and quality governance within this financially responsible, collaborative biopharma group with a strong patient focus.

Competenze

• Requires advanced degree in life sciences or related discipline.
• Proven experience leading global clinical development programs (Early Phase, Late Phase, RWE).
• Strong knowledge of ICH-GCP guidelines and regulatory requirements.

Mansioni

• Lead strategy and execution of global clinical development programs.
• Mentor Clinical Project Managers and coordinate cross-functional teams.
• Oversee end-to-end Clinical Operations activities, budgets, and vendor governance.
• Support regulatory documentation and submissions (eCTD components).
• Coach CPMs, drive risk mitigation and CAPA.
• Present updates to governance bodies and manage escalations.

Conoscenze

Project management

Stakeholder management

Leadership

Communication

Risk management

Budget oversight

Formazione

Advanced degree in Life Sciences

Descrizione del 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.

• 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 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 • rovigo, veneto, it