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Global Clinical Project Manager - Early Phase Haematology

icon · Barcelona

New
Senior 🇬🇧 English
ICH-GCP PMP PRINCE2 Clinical Study Protocol Clinical Study Report CSP CSR

Job description

About the role

ICON is a global healthcare intelligence and clinical research organisation. As part of its AstraZeneca Functional Service Provision (FSP) programme, it is recruiting a Global Clinical Project Manager to lead and drive the delivery of global early-phase haematology studies. The role sits within AstraZeneca's clinical operations team, working closely with internal teams and external partners to deliver studies on time, within budget and to high quality standards.

Key responsibilities

  • Lead, guide and delegate to a cross-functional study team or oversee outsourced delivery so that milestones are met on time, within budget and to quality standards; may oversee several studies.
  • Facilitate communication across functions, including external partners and service providers, and lead investigator and study-related meetings.
  • Contribute to and own the development of study documents from Clinical Study Protocol (CSP) to Clinical Study Report (CSR) in line with AZ SOPs.
  • Monitor external service providers (CROs, central laboratories, IXRS, ePRO, etc.) against contracted goals and timelines, document oversight and escalate issues; may take part in vendor selection.
  • Develop study plans and quality and risk management plans, including risk-based quality management and contingency plans.
  • Keep study-level system data current and accurate, and oversee performance against KPIs and plans.
  • Manage study budgets, including re-forecasting after the initial estimate, and report budget progress and financial risks to the CPT.
  • Ensure studies remain inspection-ready under ICH-GCP and AZ SOPs, and act as the main contact for audits and inspections.
  • Give regular performance feedback to study team members and mentor less experienced colleagues.

Required profile

  • Bachelor's degree in a science-related field.
  • Significant project management and team leadership experience.
  • 10 years of relevant clinical experience in the pharmaceutical industry, including 5 years of global clinical project management or equivalent early-phase haematology experience.
  • Proven track record of delivering projects on scope, time and budget.
  • Experience across all phases of clinical studies and managing multiple amendments in early-phase studies.
  • Legal right to work in the country where the role is based.

Required skills

  • Extensive knowledge of ICH-GCP and clinical research regulatory requirements.
  • Proficiency in project management tools and methodologies; PMP or PRINCE2 certification is advantageous.
  • Strong leadership, communication, stakeholder management and problem-solving skills.

What we offer

  • Competitive base salary and performance-related incentives.
  • Health and wellbeing programmes, including medical, dental and vision coverage where applicable.
  • Retirement and pension plans, life assurance and disability coverage.
  • Employee assistance programmes and learning and development opportunities.

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Source : ats:workday

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Published 4 hours ago

Expires 1 month from now

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