Global Study Manager

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ICON plc

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Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

📋 Description

• Support the planning, setup, execution, and close-out of global clinical studies. • Oversee vendors and country teams to ensure smooth study delivery. • Work closely with AstraZeneca’s internal teams and external partners. • Help develop and update study documents (e.g., protocols, informed consent forms). • Manage third-party vendors, including contracts and budgets. • Ensure all study activities comply with regulations (ICH-GCP), AstraZeneca SOPs, and best practices. • Contribute to meetings, audits, and inspections. • Support risk management and quality assurance efforts. • Maintain accurate study documentation and ensure inspection readiness at all times.

🎯 Requirements

• Bachelor’s degree (preferably in life sciences or related field). • At least 5 years’ experience in clinical research, with 3+ years in Global clinical project management/ Global Study Manager within a Pharma or CRO • Strong knowledge of clinical research regulations (ICH-GCP). • Proven ability to deliver projects on time, within budget, and to quality standards. • Experience working with internal teams and external vendors including vendor set up, management and vendor budgets. (eg. central labs, IRT etc) • Excellent communication, teamwork, and problem-solving skills. • Ability to manage multiple priorities and work in a matrix environment. • Experience in all phases of clinical study lifecycle. • Experience in haematology or oncology studies in early phase • Experience in using AI automation in your daily work as a GSM • Knowledge of GXP outside of GCP (e.g., GMP, GLP). • Desirable: Advanced degree (MSc, PhD).

🏖️ Benefits

• Various annual leave entitlements • A range of health insurance offerings to suit you and your family’s needs. • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. • Life assurance • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.