Clinical Project Lead
1 settimana fa
Clinical Project Manager – Neuro / Psychiatry
Location
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
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
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
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)
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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