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Global drug and device development services

Global Clinical Project Manager

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeNo salary listedRemote

About the Job

Requirements

  • A bachelor's degree in a science-related field is required.
  • At least 10 years of relevant clinical experience in the pharmaceutical industry, including 5 years of global clinical project management experience, or equivalent.
  • Experience in early phase hematology.
  • A proven track record of managing projects from inception to completion and delivering within scope, time, and budget constraints.
  • Experience across all phases and the lifecycle of clinical studies.
  • Experience managing multiple amendments during early phase studies.
  • Proficiency in project management tools and methodologies; PMP or PRINCE2 certification is advantageous.
  • Extensive knowledge of ICH-GCP, clinical research regulatory requirements, clinical study management processes, and clinical/drug development.
  • Strong project management skills and knowledge of relevant tools.
  • Strong team leadership abilities and experience.
  • Ability to establish and maintain effective working relationships with internal and external colleagues and stakeholders, and strong conflict management skills.
  • Strong strategic and critical thinking abilities.
  • Strong organizational and problem-solving skills.

Responsibilities

  • Lead, guide, and delegate appropriately to a cross-functional study team, or oversee outsourced delivery activities, to ensure clinical studies progress as planned and achieve milestones within timelines, budget, and quality standards; may be accountable for or oversee several studies.
  • Lead and facilitate communication across functions, external partners, and service providers; lead and conduct investigator and other study-related meetings.
  • Provide input into and hold accountability for developing essential study-level documents, from the Clinical Study Protocol through the Clinical Study Report, in accordance with relevant AstraZeneca standard operating procedures.
  • Ensure study-level external service providers, including contract research organizations, central laboratories, IXRS, and ePRO providers, meet contracted goals, timelines, and budgets; document oversight, escalate issues appropriately, and potentially participate in vendor selection.
  • Develop and maintain study plans, including study-level quality and risk management plans, risk-response strategies, contingency plans, and clear issue-escalation pathways.
  • Ensure information in study-level systems, including ACCORD/ABACUS and PharmaCM, is current and accurate.
  • Oversee study performance against agreed plans, milestones, and quality and operational key performance indicators using company tracking systems and project tools.
  • Reforecast study budgets following initial estimates provided by the CPT; manage budgets through the study lifecycle and provide the CPT with budget progress reports, financial risks, and mitigation plans as part of ongoing study change control.
  • Ensure studies remain inspection-ready according to ICH-GCP, AstraZeneca standard operating procedures, and relevant policies and guidelines; serve as the primary Study Management contact during audits or inspections.
  • Provide regular feedback on individual performance to study team members and their line managers to support professional development, and potentially mentor less experienced colleagues.

Desired Qualifications

  • PMP or PRINCE2 certification is advantageous.

About the Company

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Global drug and device development services

This company provides consulting, development, and commercialization support for drugs and medical devices through a global network of offices. Its team across 53 countries offers end-to-end services, from strategy and regulatory work to manufacturing and market access, helping clients shorten development time, lower costs, and raise quality. It differentiates itself with wide geographic reach and a clear focus on reducing time to market and cost while leveraging deep experience across many therapeutic areas. Its goal is to help clients accelerate the development of life-saving products and improve quality of life by delivering reliable information, practical solutions, and solid performance.

Company size
10,001+
Company stage
IPO
Headquarters
Ireland
Founded
1990

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