Clinical Project Lead

3 giorni fa

Milano, Lombardia, Italia Barrington James A tempo pieno

Job Title

Clinical Project Manager – Neuro / Psychiatry

Location

Milan, Italy

Department

Clinical Operations

Reports to

Senior Clinical Project Manager / Director of Clinical Operations

Job Purpose

The Clinical Project Manager (CPM) is responsible for the planning, execution, and delivery of clinical trials within Neurology and Psychiatry, ensuring studies are conducted on time, within budget, and in compliance with ICH-GCP, EU regulations, and company SOPs. The CPM will lead cross-functional teams and act as the primary operational contact for sponsors, CRO partners, and internal stakeholders.

Key Responsibilities

Clinical Trial Management

  • Lead the operational management of Phase I–IV clinical trials in Neurology and/or Psychiatry
  • Develop and maintain project plans, timelines, budgets, and risk mitigation strategies
  • Ensure trial delivery meets quality, timeline, and financial objectives
  • Oversee study start-up, site activation, enrolment, monitoring, and close-out activities

Cross-Functional Leadership

  • Coordinate internal teams including Clinical Operations, Data Management, Biostatistics, Pharmacovigilance, and Regulatory Affairs
  • Manage external vendors, CROs, central laboratories, and imaging providers
  • Chair study team meetings and ensure clear communication across all stakeholders

Site & Vendor Oversight

  • Support site selection, feasibility assessments, and investigator engagement
  • Monitor site performance, enrolment, and protocol compliance
  • Address operational challenges related to Neuro/Psych populations (e.g. recruitment, retention, patient burden)

Regulatory & Quality Compliance

  • Ensure trials comply with ICH-GCP, EU Clinical Trial Regulation (CTR), GDPR, and local Italian regulatory requirements
  • Support submissions to Ethics Committees and Competent Authorities
  • Ensure inspection and audit readiness throughout the study lifecycle

Budget & Financial Management

  • Develop and manage study budgets and forecasts
  • Track study spend and manage change orders
  • Ensure timely investigator payments and vendor invoicing

Risk & Issue Management

  • Identify operational risks early and implement mitigation strategies
  • Escalate issues appropriately and provide clear solutions to stakeholders
  • Lead corrective and preventive actions (CAPAs) when required

Therapeutic Area Focus – Neuro / Psychiatry

  • Manage trials involving CNS indications such as neurological disorders, psychiatric conditions, or neurodevelopmental diseases
  • Oversee complex assessments (e.g. rating scales, cognitive testing, imaging, digital endpoints)
  • Ensure patient-centric approaches for vulnerable populations and long-term studies

Person Specification

Essential

  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related discipline
  • Proven experience as a Clinical Project Manager or Senior Clinical Trial Manager
  • Strong experience managing Neurology and/or Psychiatry clinical trials
  • In-depth knowledge of ICH-GCP and EU clinical trial regulations
  • Demonstrated ability to manage multiple studies and cross-functional teams
  • Excellent communication, leadership, and organisational skills
  • Fluency in English (written and spoken)

Desirable

  • Experience working in Italy and familiarity with AIFA and Ethics Committee processes
  • CRO and/or sponsor-side experience
  • Experience with decentralised or hybrid trial designs
  • Master's degree or project management certification (e.g. PMP, PRINCE2)
  • Fluency in Italian

What We Offer

  • Opportunity to work on innovative CNS clinical trials
  • International and collaborative working environment
  • Competitive salary and benefits package
  • Professional development and career progression opportunities

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