Overview
As a Feasibility Strategy & Analytics Lead (FSAL), you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities
- What you will be doing:
- The Feasibility Strategy & Analytics Lead (FSAL) is the single point of contact for the study team in the build of evidence driven study assumptions to provide a country and site strategy that includes a list of proposed countries and sites to be targeted during site feasibility/selection, enrollment scenarios, and protocol optimization strategies. POD FSALs will partner closely with OARS (Optimization, Analytics, & Recruitment Solutions) to ensure connection to platform functions within OARS. FSALs may be re-engaged to support study team enrollment to assess future changes to that strategy (e.g. plan adjustments or rebaseline) through the completion of participant recruitment.
- Implementing processes related to country & site intelligence and provide continuity by connecting and documenting changes throughout the lifecycle (from early estimates, early feasibility, detailed assumptions, detailed feasibility, to participant recruitment, study start-up planning and last subject first visit).
- Provides early feasibility (before core protocol elements are available) by providing initial enrollment timelines, potential country footprint, primary intelligence gathering (benchmark studies, competitive landscape, treatment approvals etc), and key enrollment assumptions to inform initial high level Op Plan assumptions.
- Introduces opportunities for protocol optimization by leveraging available real world data, investigator insights, and patient insights, and coordinates with relevant functions to incorporate these insights in study assumptions.
- As protocol elements evolve to final protocol and start up stages, the Feasibility Strategy & Analytics Lead (FSAL) will continue to evolve detail on country footprint, enrollment assumptions, and appropriate site segmentation strategy.
- Support the build of the investigator database, collection of information supporting the definition of the ideal site for a study, identification of suitable sites for a study, and coordinate global efforts for site intelligence.
- Author and maintain oversight of both Country and Site Feasibility outreach and engagement, lead response reviews with appropriate study team members, and provide strategic input into team decision making.
- Analyze results of outreach and evidence to build the recommended country and site strategy.
- Provide summary site analytics as the volume of sites is progressed through evaluation stages to Pre Trial Assessment (PTA) to ultimate Site Selection. Analytics include modeling volume of patients (by site segmentation); ability of site mix to achieve clinical trial diversity goals; competition, site overlap and other key parameters identified as performance drivers by study team.
- Leveraging the totality of data available (internal, external and regional intelligence), provide strategic scenarios based upon team input and request, to team on options and levers to optimize site footprint and enrollment timelines.
- Partners with CD&O teams, and RU/BU partners to improve overall study start up and recruitment cycle time metrics.
- Operational responsibility for delivering to agreed set of KPIs for assigned protocols.
- Promotes a continuous improvement culture to streamline appropriate processes for maximum efficiency and productivity through uptake of innovative strategies.
- Influences alignment of business strategies that promote the widespread implementation of suitable clinical trial technologies.
- Maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitates effective portfolio delivery.
Qualifications
You are:
- BS / RN / MS & 7 years relevant experience
- PhD / MD and 3 years relevant experience
- Knowledge of Drug development, a thorough understanding of the processes associated with global country and site feasibility, clinical study start-up and business operations.
- Experience in clinical research, including clinical trial conduct, knowledge of GCP and a good understanding of the processes associated with study/project management, monitoring, clinical and regulatory operations.
- History of success in a customer service role with demonstration of meeting customer expectations.
- Strong verbal and written communication skills. Effective presentation and facilitation skills.
- Well-developed strategic planning, observation, analytical operational execution and problem-solving skills.
- Strong business consultancy skills, including ability to persuade, negotiate, and moderate conflict.
- Ability to multitask under tight deadlines on several projects with specific and unique requirements, while providing attention to detail and high quality work.
- Able to synthesize key messages pulling across multiple data sets.
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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