Global Clinical Project 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

• Lead, provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget and quality standards. • May hold accountability and/or oversight of several studies. • Lead and facilitate communication across all functions, including external partners and service providers. • Lead and conduct investigator meetings and other study related meetings. • Provide input into and hold accountability for the development of essential study level documents (i.e., Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant AZ SOPs. • Ensure all external service providers (i.e., Contract Research Organizations (CROs), central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented and any issues are escalated appropriately. • May participate in vendor selection activities. • Develop and maintain relevant study plans including required input into study level quality and risk management planning (e.g., risk-based quality management, proactive risk and contingency plans, etc.) ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team. • Accountable for ensuring that information in all systems utilized at a study-level (e.g. ACCORD/ABACUS, PharmaCM, etc.) are current and accurate. • Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project. • Responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans (as part of the ongoing study change control process). • Ensure studies are inspection-ready at all times, according to ICH-GCP and AZ SOP and relevant policies/guidelines; • You will be the primary Study Management point-of-contact in the event of an audit or inspection. • Provide regular feedback on individual performance to the study team members and their line managers to support their professional development; may mentor less experienced colleagues.

🎯 Requirements

• Bachelor’s degree in Science related field is a must, with significant experience in project management and team leadership. • 10 years of relevant clinical experience in the pharmaceutical industry, including 5 years’ Global clinical project management experience, or equivalent Early Phase Hematology experience. • Proven track record of successfully managing projects from inception to completion, with a focus on delivering results within scope, time, and budget constraints. • Strong leadership and organizational skills, with the ability to effectively manage project teams and prioritize tasks. • Experience across all Phases and lifecycle of the clinical studies. • Experience managing multiple amendments during early phase studies. • Excellent communication and interpersonal skills, with the ability to build relationships and manage stakeholder expectations. • Proficiency in project management tools and methodologies, with certifications such as PMP or PRINCE2 being advantageous. • Detail-oriented, proactive, and adaptable, with a commitment to achieving project goals and driving continuous improvement. • Extensive knowledge of ICH-GCP, clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development. • Demonstrated solid project management skills and knowledge of relevant tools. • Strong, demonstrated abilities/skills in team leadership. • Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills. • Strong strategic and critical thinking abilities. • Strong organizational and problem-solving skills.

🏖️ 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.