Global Study Lead

As a Global Study Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

ICON Romania are currently looking for a Global Study Leader who will join our FSP team at ICON and manage non-interventional studies.

What you will be doing:

• As a Global Study Lead you will be responsible for planning and leading the delivery of non-interventional studies to time, quality, budget, company standards and scientific requirements
• You will lead the study delivery team of functional subject matter experts and function as the Study Accountable Person for all ICH GCP and SOP-driven activities.
• Effective oversight of the delivery of studies or programs that are outsourced to sponsor’s preferred CROs.
• Coordination of Study Protocol development
• Lead escalation and resolution of any issues with CRO/ vendors/ site/ country performance raised by the study team
• Maintain regular interaction with all study team members to ensure issues / risks / successes with study delivery are reviewed and/or shared as they occur.
• Lead key discussions with CRO suppliers to ensure appropriate expectations have been set and CRO are aligned on delivery strategy
• Encourage CRO to take accountability for quality data delivery
• Provide holistic oversight of CRO – understand study contribution to program/submission
• Accountability for study delivery strategy (e.g. country selection, diversity, patient engagement strategy etc)
• Single point accountability for the operational delivery of clinical study to time, quality and budget (through to completion of TMF archiving)
• Drive assessment, selection, engagement and management of appropriate vendors for outsourced clinical activities/services;
• Ensure inspection readiness for study at all times and overall accountability for eTMF
• Ensure development, review, finalization and delivery of high-quality key clinical study documents in order to meet study timelines
• Manage internal and external stakeholders through appropriate engagement and communication
• Provide leadership at study level to ensure accuracy, quality and timeliness of update of operational data maintained in systems used to track studies

Requirements:

• University degree

• Previous project management experience, idelly in manaing non-interventional studies

• Ability to lead cross-functional team – set priorities and performance targets in a global environment;

• Creative thinker - able to modernize approach to study delivery

• Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment

• Effective problem solving and conflict resolution skills with a solutions-oriented mindset

• Operational expertise in risk management and contingency planning
  
  

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 maximise 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested 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.

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