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 xysqume 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

📌 Clinical Operations Lead (Caserta)
🏢 Chiesi
📍 Caserta