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

By joining our AstraZeneca FSP program, you’ll collaborate with an award-winning biopharmaceutical leader, renowned for innovation, inclusion, and making a real difference in patients’ lives. As a Global Clinical Project Manager where you will be managing and driving the delivery of global Early phase Haematology studies, you’ll be fully integrated into AstraZeneca’s clinical operations team, helping to deliver innovative, global clinical studies in haematology. You’ll ensure projects are completed on time, within budget, and to the highest quality standards, working closely with both AstraZeneca’s internal teams and external partners.

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 commu