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.
Delivery of clinical trial analytics and insight generation with regards to feasibility operations and predictive trial enrollment. The Feasibility Analytics Manager (FAM) will interact directly with various stakeholders to identify and deliver solutions for disease specific market analysis, benchmarking, country tiering, site selection and enrollment modeling.
These services require close collaboration with other FAMs, Feasibility Analytics Head, Feasibility Analytics Innovation team and Global Feasibility Leads who oversees the feasibility at program and protocol levels.
Implementation and utilization of new technology initiatives related to feasibility and enrollment modelling. This role will be hands on with key feasibility and operational databases and technology platforms, collect clinical data for analysis, generate insights, review with feasibility teams and optimize patient enrollment scenarios.
The individual is expected to stay abreast of optimizing trends within the Therapeutic Area (TA) and understand the competitive landscape.
What you will be doing:
- Adhere to applicable SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
- Provide Standard Analytical Product Package E2E services with regards to feasibility as part of the End to End Process (E2E) within Global Development, aligned with the program level strategy within the agreed timelines and at the highest quality standards. Intelligence services include:
- Services such as external/internal benchmarking, competitive landscape, country tiering, site profiling
- Scenario planning, creating enrollment projections and facilitate plan building and study enrolment progress tracking in information systems (e.g. Monte Carlo Simulations, Study Optimizer)
- Ultimately responsible for validating, checking and managing the correct and complete production of standard analytical packages through internal teams and vendor teams
- Consult with Global Feasibility Heads/Leads on insights that should be exemplified and highlighted and connect the data with application to trial operational design and efficiency
- Provide intelligence regarding program planning, protocol design, country and site placement, and enrollment modelling utilizing data-driven approaches to influence optimized approaches to clinical trial execution
- Collect and report on clinical trial performance metrics regarding trial placement, optimization, and enrollment
- Drive the implementation and improvement of Feasibility initiatives/processes/technologies to support and continually evolve standard analytics
- Enable tactics to support the Feasibility Lead in program and protocol planning deliverables such as recruitment rates, site numbers, enrollment estimates, country footprint, startup timelines, impact of protocol criteria, and site and patient profiles
- Function as a System Matter Expert (SME) for operational feasibility systems for internal and external customers
- Track efficiencies resulting from the implementation of new technology initiatives related to program planning, country and site selection, enrollment tracking and protocol optimization
- Establish and follow operational enrollment technology and operational business processes
- Stay informed of clinical trial optimizing trends within Therapeutic Area (TA)s, data analytics, and technologies and promote KPIs to influence optimizing behavior. Ensure appropriate escalation of technology & vendor issues as needed
- Coordinate with and support Feasibility Data Sciences to grow and create data-generated insights and visualizations
- Participate in Global Development initiatives as assigned.
You are:
- Bachelor’s Degree is required, preferably in a scientific or health-related discipline. A Master’s Degree, or higher, is preferred
- At least 5 years of relevant experience in clinical trial execution with a pharmaceutical company and/or a CRO
- Expertise in the areas of drug development, clinical trial operations, and strategic planning
- Experience in driving and implementing new technologies
- Excellent communication skills and the innate flexibility to work in a rapidly growing organization
- Strong understanding and experience with information systems (e.g., CTMS, Study Optimizer) and an understanding of basic statistical and epidemiological principles
- Ability to apply data insights to optimize a strategy or scenario
- Strong planning and tracking skills, customer focused, well organized, detail oriented and capable of successfully managing multiple projects
- Excellent time, priority, and self-management capabilities
- Proficient MS Office capabilities (e.g. Excel, PowerPoint and Word)
Required:
- Experience in statistical analysis and analytical models- especially in enrollment modelling, simulation and forecasting
- Strong understanding of clinical trial operations data
- Advanced skills in MS. Office Skills, Tableau or other visualization software
- Effective leadership skills and a proven ability to foster team productivity and cohesiveness
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.
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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