Clinical Operations Lead

Chiesi; Caserta; In loco; EUR 90.000 - 135.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Remote work options

Descrizione del lavoro

Chiesi in Caserta, Campania, Italy, seeks a Clinical Operations Lead to guide global clinical development programs across Early Phase, Late Phase, and RWE studies. You will align cross-functional teams, mentor CPMs, and oversee end-to-end operations with a strong focus on quality and budget discipline.

The role requires deep CDP planning, ICH-GCP knowledge, and extensive vendor management experience in pharma or CRO settings, with responsibility for governance, risk mitigation, and regulatory

Competenze

• 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 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

Mansioni

• 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.

Conoscenze

Program strategy

Cross-functional leadership

Vendor management

Budget oversight

Risk management

CPM coaching/mentoring

Stakeholder management

Presentation skills

Communication

ICH-GCP

CDP planning

Formazione

Advanced degree in Life Sciences, Pharmacy, Medicine, or related discipline

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 caserta, campania, it