Clinical Operations Lead

TL;DR

Clinical Operations Lead: Providing strategic and operational leadership across complex global clinical development programs with an accent on integrating Clinical Operations activities across Early Phase, Late Phase, and Real-World Evidence (RWE) studies. Focus on end-to-end program oversight, vendor/CRO governance, risk & inspection readiness, and clinical documentation support for regulatory submissions.

Location: Italy (HQ in Parma) with flexibility for hybrid or predominantly remote setup depending on candidate location and experience

Salary: €62,500 minimum

Company

International research-focused biopharmaceutical group developing and marketing innovative drugs across multiple therapeutic areas.

What you will do

• Lead program strategy and ensure alignment/integration of studies within the Clinical Development Plan (feasibility, timelines, geographic strategy, budget).
• Oversee end-to-end Clinical Operations activities and support Clinical Project Managers (CPMs) on operational decisions and compliance (ICH-GCP, SOPs).
• Manage vendor/CRO strategy, including RFP support, evaluations, bid defense meetings, escalations, and vendor governance.
• Own program-level budget oversight, supporting planning/forecasting and variance analysis with Finance.
• Drive governance and stakeholder management across program bodies (e.g., CPRF, PRM, XRC) and present program updates, risks, and mitigations.
• Ensure risk mitigation, CAPAs, inspection readiness, and support clinical documentation for regulatory submissions (eCTD, CSR/CIR).

Requirements

• Advanced degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline.
• Significant Clinical Operations experience in pharmaceutical/biotechnology or CRO environments.
• Proven experience managing global clinical development programs across Early Phase, Late Phase, and Real-World Evidence (RWE).
• Strong knowledge of clinical drug development processes and Clinical Development Plans (CDPs), including integrated timelines and milestones.
• Solid understanding of ICH-GCP, applicable regulatory requirements, and clinical research best practices.
• Fluency in English (written and spoken).

Culture & Benefits

• Hybrid or predominantly remote working arrangement depending on candidate location and experience.
• Annual bonus scheme eligibility based on company and individual performance.
• Comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits, and ticket restaurant.
• Relocation support and tax assistance services for foreign colleagues.
• Training and development resources to support career growth.

Hiring process

• Interviews focused on clinical operations leadership, global program oversight, and cross-functional collaboration.
• Assessment of experience with vendor/CRO management, governance bodies, and regulatory documentation (eCTD/CSR/CIR).
• Final discussions aligned to role scope, location fit (Parma/hybrid/remote), and compensation framework.