Global Study Lead

Global Study Lead - Oncology - Home Based

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.

Role combines end-to-end design, execution, and reporting of clinical trials with leadership in project teams and across matrix teams. This position within GCD is accountable for planning and leading the delivery of clinical studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study proposal.  This involves generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds.

The role may span from early through to late phase of development and include delivery through one or more in-house, outsourced and alliance delivery models.  This role is highly visible within Global Clinical Operations and in the Clinical Matrix Teams.

Key attributes include:

Demonstrated ability to input and influence studies/projects through operational expertise and demonstrated excellence in stakeholder management. This job requires competent strategic thinking, solution-finding, and agility as evidenced by flexibility, adaptability to change, curiosity, and ability to lead and drive change.

Essential behaviors include proven global leadership, continuous improvement and learning, effectiveness at building networks of partners and stakeholders, and ability to lead and inspire others. A track record of applying experience and judgement towards agile project decision-making, effective peer review, and shared learning is essential.

Key Responsibilities

• Accountable for the global study delivery strategy (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc.) and for overall study deliverables.

• Drive assessment, selection, engagement, management, and oversight of appropriate vendors.

• Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and sponsor SOPs, for all products and services delivered for their designated studies.

• Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate.

• Work with matrix partners, asset lead and/or manager to develop and manage study level budget within project allocation

• Preparation of materials for governance and / or financial review cycles and provide expert clinical operational input into protocol development.

• Lead and conduct investigator meetings and other study related meetings and participate in governance meetings as necessary.

• Identify and communicate resource gaps for assigned studies.

• Lead risk management and quality efforts to ensure study compliance and continual inspection readiness.

• Lead / contribute to ways of working and process improvement initiatives.  Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.

• Partner with Data Management and Clinical Sciences to develop the data cleaning strategy for the study and collaborate with aligned staff in global functions to deliver the Clinical Study Report.

• Work with the patient councils to develop patient centric documents and address patient burden.

What you need to have:

• Bachelor’s degree in life sciences or related discipline.

• Extensive clinical development experience that is equivalent to 5+ years as a global study leader with proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment.

• Proven operational experience leading global clinical trials and knowledge of essential global regulatory guidelines and ICH/GCP.

• Proactively identify and resolve issues to ensure timely study delivery to quality, timelines, and budget.

• Proven leadership skills, influencing and negotiation skills.

• Demonstrated experience leading in the matrix environment to deliver projects, develop clinical plans and manage change.

Preferred Qualifications

• Oncology phase III global registrational study leadership experience.

• Proven clinical development experience across all phases of development (I-IV).

• Experience of innovative trial design (platform, basket, umbrella, adaptive designs) and decentralized trials (DCT) initiatives.

• Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary and ability to manage conflict.

• Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams.

• Creative thinker able to modernize approach to clinical delivery, leverage externally.

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

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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