Manager, Clinical Research Modeling & Forecasting
- Responsible for line management / mentoring / coaching of the Modeling team including coordination and evaluation of the team
- Oversight of the team accountable for the development, analysis, interpretation and presentation of evidence-based planning for implementation to deliver clinical trials
- Obtain and assess the relevant strategic/ operational data and additional information to develop robust patient recruitment models to support business decisions and objectives
- Analyse data for quality, correctness and context
- Using the patient recruitment model generate additional forecasts - eg
- Endpoint projections
- Site Performance Indicators
- Data volume for workload assessments
- Visit and timeline projections for resourcing
- Investigator budgets - financial management
- Lead the work on complex/large studies. Oversee program level department tasks
- Deliver accurate, high quality deliverables to timelines and expectations
- Third party QC of Modeling deliverables
- Undertake adhoc report requests, generate specs and outputs. Identify new reports required by groups / departments and work with them to create to their needs
- Provide advice, oversight and ongoing support to cross functional global teams in the use of the Modeling outputs and analysis. Provide recommendations, positioning and options based on the analysis of the data received and modelled. Tracking of performance metrics and applying these metrics to forecast activities for on-going projects as requested
- Provide oversight of accuracy and quality of all modelling deliverables including study reports, study tracking, data for metrics reporting and Modeling documentation including user manual / work instructions
- Identifying projects requiring Modeling or data analysis support, in conjunction with the Project Team
- Lead internal study team and client meetings specific to the Modeling. Actively participate in Project Review meetings and address key points applicable to Modeling.
- Train Modeling team members in new processes and tools created. Train study teams in Modeling and Forecasting tools and processes.
- Provide overview and capabilities presentations both internally and externally
- Identify, propose and support potential solutions to improvement areas of the department's tools and processes. Identify gaps in the current tools and propose new tools or solutions.
- Lead the development and communication of technical plans (specs) for program development, enhancements and implementation - where necessary run, modify or create programs or mock up outputs to support the prototyping of tools
- Drive the evolution and refinement of department tools by reviewing inputs / outputs and stress testing the new tools.
- Provide guidance and direction to the software developers in the industrialisation and deployment of new tools/software. Participate in UAT and regression testing.
- Drive the identification of novel applications of department / informatics tools and support the development and implementation
- Support and guide S&P and Feasibility in pre-award modelling activities or provide relevant forecasts and supporting text for inclusion in RFP/RFIs and convert to presentation format for Bid Defence Meetings
- Participate and support workstreams, initiatives, development of new tools and technologies. Lead any department participation. Feedback to the department on progress and requirements
- Provide data and input for internal and external presentations. As required present to internal and external groups and departments
- Work on any other tasks as delegated and cover for department head as requested and directed.
- University/college degree (preferably in Sciences, Maths or Statistics) or equivalent experience in a proven ability to learn new tasks and data analysis
- Demonstrate a high level of ability in performing complex data analysis and statistical modelling (as applicable)
- Practical experience and understanding of global drug development and clinical trials including demonstrated experience for the mining, manipulating and presenting of complex scientific data as it relates to clinical research and market analyses
Years of experience in the job discipline - Minimum of 5 years work experience relevant to informatics modeling and/or data analysis
Years of experience in other professional roles - At least 5 years work experience within the Pharmaceutical Industry
Other required work-related experiences -
- Exposure to work experience or relevant degree/diploma course relevant to informatics modeling and/or statistical analysis
- Demonstrate the ability to lead large initiative projects independently.
- Proven ability to position Modeling outputs (or similar) to customers and understand their needs.
- Experience in mentoring and coaching staff in a technical role
- Track record of process and tool improvements to drive growth
Position Specific Requirements
- Strong technical/scientific writing skills and analytical skills
- Strong hands-on data mining and analytical skills with the abilities to review/analyse relevant data so as to assist in building evidence-based clinical trial strategies
- Strong affinity for numbers and attention to detail/quality control skills
- Upholds the highest standard of personal professionalism and work integrity
- Strong networking abilities and an ability/willingness to work with individuals across the globe. Persistent, persuasive and able to influence others
- Excellent communication, planning & organizational skills
- Creative, effective and efficient problem solving skills
- Ability to work independently and successfully within a team. Ability to work across multiple teams and take the lead as directed.
- Demonstrated ability to handle multiple competing priorities effectively. Comfortably be able to reset expectations.
- Ability to set-up and/or modify the models or tools (i.e. develop algorithms) and model / process the relevant data
- Able to prioritise workload for self and for people being mentored appropriately
- Understanding and practical working knowledge of ICH-GCP Guidelines, including relevant international requirements/guidelines for the conduct of global clinical development programs
- Understanding of global drug development and the clinical trial project management process, with a special emphasis on investigator sites, patient recruitment and retention
- Excellent computer skills, including strong working knowledge of Microsoft Office and other data capture and compilation tools. Ability to understand and access and leverage technology alternatives
- High level knowledge of Excel
- Strong knowledge of Modeling and associated tools
- Strong skills in scientific data manipulation, analysis, reporting and maintenance
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