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ppGlobal Clinical Project Manager /ppICON 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. /ppAs 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 /ppbTherapeutic Area: /b Haematology (Oncology Hematology) bEarly Phase /b /ppBy 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. /ppbWhat You Will Be Doing: /b /pullih3Lead, 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. /h3 /lilih3Lead and facilitate communication across all functions, including external partners and service providers. Lead and conduct investigator meetings and other study related meetings. /h3 /lilih3Provide 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. /h3 /lilih3Ensure 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. /h3 /lilih3Develop 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 /h3 /lilih3Accountable for ensuring that information in all systems utilized at a study-level (e.g. ACCORD/ABACUS,
PharmaCM, etc.) are current and accurate. /h3 /lilih3Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project /h3 /lilih3Responsible 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) /h3h3Ensure 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 /h3h3Provide regular feedback on individual performance to the study team members and their line managers to support their professional development; may mentor less experienced colleagues /h3 /li /ulpbYour Profile: /b /pullipBachelor’s degree in Science related field is a must, with significant experience in project management and team leadership. /p /lilip10 years of relevant clinical experience in the pharmaceutical industry, including 5 years’ General clinical project management experience, or equivalent /p /lilipEarly Phase Hematology experience /p /lilipProven track record of successfully managing projects from inception to completion, with a focus on delivering results within scope, time, and budget constraints. /p /lilipStrong leadership and organizational skills, with the ability to effectively manage project teams and prioritize tasks. /p /lilipExperience across all Phases and lifecycle of the clinical studies /p /lilipExperience managing multiple amendments during early phase studies /p /lilipExcellent communication and interpersonal skills, with the ability to build relationships and manage stakeholder expectations. /p /lilipProficiency in project management tools and methodologies, with certifications such as PMP or PRINCE2 being advantageous. /p /lilipDetail-oriented, proactive, and adaptable, with a commitment to achieving project goals and driving continuous improvement. /p /lilipExtensive knowledge of ICH-GCP,
clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development /p /li /ulullipDemonstrated solid project management skills and knowledge of relevant tools /p /lilipExcellent communication and interpersonal skills /p /li /ulullipStrong, demonstrated abilities/skills in team leadership /ppStrong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills /p /lilipStrong strategic and critical thinking abilities /p /lilipStrong organizational and problem-solving skills /p /li /ulpbWhat ICON can offer you: /bbrOur 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. /ppIn 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. /ppOur benefits examples include:br/pulliVarious annual leave entitlements /liliA range of health insurance offerings to suit you and your family’s needs. /liliCompetitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. /liliGlobal 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. /liliLife assurance /liliFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. /li /ulpVisit our a careers site /a to read more about the benefits ICON offers. /ppAt 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. /ppIf, 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 a here /a /ppInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. /ppAre you a current ICON Employee? Please click a here /a to apply /p /p #J-18808-Ljbffr
📌 Global Clinical Project Lead, Haematology (Early Phase) (Barcelona)
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📍 Barcelona