Global Clinical Project Manager

Global Clinical Project Manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As the world’s largest provider of Functional Service Provision (FSP), ICON Strategic Solutions embeds our teams within client organisations, serving as dedicated partners to some of the world’s leading pharmaceutical and

Therapeutic Area: Haematology (Oncology & Hematology) Early Phase

What You Will Be Doing:

• 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

Your Profile:

• 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

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here