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
Effectively partner with CROs to 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. SME for systems as assigned
Requirements
Bachelor’s Degree is required, preferably in a scientific or health-related discipline.
A Master’s Degree, or higher, is preferred
Experience in statistical analysis and analytical models
especially in enrollment modelling, simulation and forecasting
Strong understanding of clinical trial operations data
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
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).
Benefits
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, 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.