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Manager, Clinical Research Modeling & Forecasting

Laboratory Corporation of America Holdings (Covance)

Bulgaria

<h2>Job Overview:</h2><ul><li style="margin-left: 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Responsible for line management / mentoring / coaching of the Modeling team including coordination and evaluation of the team</span></li><li style="margin-left: 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Oversight of the team accountable for the development, analysis, interpretation and presentation of evidence-based planning for implementation to deliver clinical trials</span><ul><li style="margin-left: 54.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Obtain and assess the relevant strategic/ operational data and additional information to develop robust patient recruitment models to support business decisions and objectives</span></li><li style="margin-left: 54.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Analyse data for quality, correctness and context</span></li><li style="margin-left: 54.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Using the patient recruitment model generate additional forecasts – eg</span><ul><li style="margin-left: 90.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Endpoint projections</span></li><li style="margin-left: 90.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Site Performance Indicators </span></li><li style="margin-left: 90.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Data volume for workload assessments</span></li><li style="margin-left: 90.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Visit and timeline projections for resourcing</span></li><li style="margin-left: 90.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Investigator budgets – financial management</span></li></ul></li><li style="margin-left: 54.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Lead the work on complex/large studies. Oversee program level department tasks</span></li><li style="margin-left: 54.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Deliver accurate, high quality deliverables to timelines and expectations</span></li><li style="margin-left: 54.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Third party QC of Modeling deliverables</span></li><li style="margin-left: 54.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Undertake adhoc report requests, generate specs and outputs. Identify new reports required by groups / departments and work with them to create to their needs</span></li></ul></li><li style="margin-left: 21.3pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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 </span></li><li style="margin-left: 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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</span></li><li style="margin-left: 21.3pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Identifying projects requiring Modeling or data analysis support, in conjunction with the Project Team </span></li><li style="margin-left: 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Lead internal study team and client meetings specific to the Modeling. Actively participate in Project Review meetings and address key points applicable to Modeling.</span></li><li style="margin-left: 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Train Modeling team members in new processes and tools created. Train study teams in Modeling and Forecasting tools and processes.  </span></li><li style="margin-left: 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Provide overview and capabilities presentations both internally and externally </span></li><li style="margin-left: 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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.</span></li><li style="margin-left: 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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</span></li><li style="margin-left: 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Drive the evolution and refinement of department tools by reviewing inputs / outputs and stress testing the new tools.</span></li><li style="margin-left: 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Provide guidance and direction to the software developers in the industrialisation and deployment of new tools/software. Participate in UAT and regression testing.</span></li><li style="margin-left: 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Drive the identification of novel applications of department / informatics tools and support the development and implementation </span></li><li style="margin-left: 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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 </span></li><li style="margin-left: 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Participate and support workstreams, initiatives, development of new tools and technologies. Lead any department participation. Feedback to the department on progress and requirements</span></li><li style="margin-left: 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Provide data and input for internal and external presentations. As required present to internal and external groups and departments</span></li><li style="margin-left: 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Work on any other tasks as delegated and cover for department head as requested and directed.</span></li></ul><h2>Education/Qualifications:</h2><ul><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">University/college degree (preferably in Sciences, Maths or Statistics) or equivalent experience in a proven ability to learn new tasks and data analysis</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Demonstrate a high level of ability in performing complex data analysis and statistical modelling (as applicable)</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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</span></li></ul><h2>Experience:</h2><h2><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Minimum Required: </span></h2><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Years of experience in the job discipline – Minimum of 5 years work experience relevant to informatics modeling and/or data analysis</span></p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Years of experience in other professional roles - At least 5 years work experience within the Pharmaceutical Industry</span></p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Other required work-related experiences - </span></p><ul><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Exposure to work experience or relevant degree/diploma course relevant to informatics modeling and/or statistical analysis </span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Demonstrate the ability to lead large initiative projects independently.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Proven ability to position Modeling outputs (or similar) to customers and understand their needs.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Experience in mentoring and coaching staff in a technical role</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Track record of process and tool improvements to drive growth</span></li></ul><p style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Position Specific Requirements</strong></span></p><ul><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Strong technical/scientific writing skills and analytical skills </span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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 </span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Strong affinity for numbers and attention to detail/quality control skills</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Upholds the highest standard of personal professionalism and work integrity </span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Strong networking abilities and an ability/willingness to work with individuals across the globe. Persistent, persuasive and able to influence others </span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Excellent communication, planning & organizational skills </span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Creative, effective and efficient problem solving skills</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to work independently and successfully within a team. Ability to work across multiple teams and take the lead as directed.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Demonstrated ability to handle multiple competing priorities effectively. Comfortably be able to reset expectations.</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to set-up and/or modify the models or tools (i.e. develop algorithms) and model / process the relevant data </span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Able to prioritise workload for self and for people being mentored appropriately</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Understanding and practical working knowledge of ICH-GCP Guidelines, including relevant international requirements/guidelines for the conduct of global clinical development programs</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Understanding of global drug development and the clinical trial project management process, with a special emphasis on investigator sites, patient recruitment and retention</span></li></ul><p style="margin-left: 18.0pt;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"> </span></p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Technical Requirements</strong></span></p><ul><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; color: black; font-family: arial, helvetica, sans-serif;">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</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; color: black; font-family: arial, helvetica, sans-serif;">High level knowledge of Excel</span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; color: black; font-family: arial, helvetica, sans-serif;">Strong knowledge of Modeling and associated tools </span></li><li style="margin-left: 18.0pt;"><span style="font-size: 12pt; color: black; font-family: arial, helvetica, sans-serif;">Strong skills in scientific data manipulation, analysis, reporting and maintenance</span></li></ul><p style="margin: 0px;"> </p><p style="margin: 0px;"> </p>

Job posted: 2021-10-30

3
Abonner