Supports the functional objectives of Clinical Trial Analytics: Forecasting by partnering with team members to perform a variety of project-oriented duties in support of study start-up, enrollment planning and reporting activities, as well as department and Global Clinical Operations initiatives. Able to perform standard deliverables independently.
• Prepares and leads target setting process among countries selected to participate in a clinical trial.
• Creates country level accrual plans which roll up to study level accrual plan, identifying planned interim milestones and enrollment closure dates.
• Supports the production of analytics that track actual enrollment at the study and country level, alerting the Clinical teams to relevant changes in actuals that may impact study timelines or performance.
• Responsible for scenario modeling (re-projection and re-planning) and accrual forecasting by gathering data from various sources (i.e., IVRS, eDM/SMT, Eclipse, Lab data), collaborating with Clinical Trial Analytics: Feasibility to determine the likelihood of the scenarios, and inform Clinical teams.
• Determines study tracking requirements (eg, cohort or country capping) and produces analytics and insights to share with stakeholders, and ensures needs are met.
• Supports global site selection through the creation and deployment of analytics and metrics that incorporate insights from historic performance measures for potential investigators.
• Translates customer requests into deliverables.
• Provides support to Clinical teams in preparation of operational review meeting and other oversight committees
• Supports end of enrollment forecasting, including cohort and capping information where appropriate.
• Provides recommendations and/or at least ensures the study team has data to make informed decision of when to end enrollment (LPFV) to meet the target number of subjects enrolled and treated.
• Supports subject retention tracking by site and country where appropriate
• Provides ad hoc analysis of trends within and across protocols to identify opportunities for improvement or creating cost effective synergies.
• Where applicable contributes to the optimization of reporting platforms and dashboards.
• Supports specific requests for more advanced data insights, visualizations and decision packets.
• Supports department and GCO initiatives, providing data, metrics, analysis and recommendations. (Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
- Education - BS degree in a scientific discipline (e.g. information science, epidemiology, health care)
- Experience - 3-5 years' experience in clinical information services support
- Experience working in a matrix environment; Experience working in a clinical research environment; Clinical or pharmaceutical/healthcare industry experience
- Experience working with vendors is preferred
- Competencies -Strong Excel skill-set, including working with formulas, graphs, pivot tables, and preferably macros
- Good understanding of clinical trial processes and analytical techniques
- Strong oral, written and interpersonal communication skills
- Strong analytical skills
- Knowledge of Clinical Trial Management System tools (i.e., CTMS/Eclipse) and Software that must be used independently and without assistance
- Demonstrated proficiency in standard Microsoft Office tools (including Outlook and SharePoint)