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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Associate Director Clinical Trial Design Clinical Costing


Reference:SCA011986 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Associate Director Clinical Trial Design Clinical Costing
Our client, a global pharma organisation, are currently recruiting for an Associate Director of Clinical Trial Design Clinical Costing to join their global centre of excellence on a permanent basis. The ideal candidate will be experienced in clinical development and clinical trials cost forecasting. This is a hybrid working role.

Responsibilities:

  • Develop strong working relationships with collaborators (i.e., CDDA functional leadership, Design Hub, Clinical Laboratory Sciences, Procurement, Clinical Development, finance, and development teams)
  • Document and update CDDA resource models used in Prism
  • Develop modelled and/or manually generated project forecast and scenario cost estimates for clinical activities
  • Maintain accurate forecast information in PRISM for assigned projects and CDDA functions and grant/nongrant costs
  • Maintain Power BI forecasting reports for clinical trials and clinical functions
  • Inform needed model changes and partner with collaborators to ensure approved resource estimations are reflected accurately and timely in PRISM for clinical components
  • Partner with RMF, ClinDev, CDDA leadership and BU Finance Analysts on the development of key messages related to clinical forecast outcomes and troubleshooting clinical cost variances
  • Influence clinical development team members to consider cost effective options and provide optionality to teams based on prior experience and expertise
  • Anticipate changing collaborator needs and adapt to change effectively while considering LRL strategic initiatives, technology options, operational implications, and impact on people as it relates to clinical costing and forecasting
  • Incorporate high-level Decentralized Clinical Trial (DCT) costing information into clinical cost estimates/ tools in partnership with CDDA functions who own DCT workstreams
  • Provide clinical trial cost breakdown for CDDA leadership cost comparison analysis (eg, Cost Per Patient breakdown)
  • Develop/maintain new aggregate level grant cost estimate tools and techniques for forecasting activities in collaboration with CDDA functions
  • Lead special projects as needed
  • Partner with the Project Management Systems, Project Management Office and RM&F teams to drive continuous improvement to systems and reporting of clinical components (Prism)
  • Proactively establish, implement, and monitor business processes to deliver accurate and timely clinical cost information
  • Support alignment between Clinical Development, RM&F and clinical cost services provided by understanding and managing linkages within Vault Clinical and other systems as appropriate
  • Proactively identify impact of issues/changes on the process, people, and points of integration for clinical cost components
  • Partner with CDDA for maintenance and update of clinical forecasting processes documented in cDOS

Requirements:
  • Education: BS degree or 10 years of experience in industry professional role
  • Business Acumen - Minimum 3 years of experience working with drug development
  • Strong preference for capacity planning, forecast estimation and/or drug development experience in Clinical functional areas
  • Knowledge of PRISM, Vault Clinical, eCTS and similar
  • Ability to influence without authority (i.e. through informal or formal leadership and effective communication) value management for programs, projects, products, and trials across the organisations portfolio
  • Ability to build strong relationships and influence across multiple levels in an organization
  • Ability to anticipate and recognize issues, diagnose root causes, propose creative alternatives, implement change, measure results, share learnings, and create and implement best practices
  • Ability to learn quickly and adapt to work assignments flexibly
  • Ability to understand the vision and strategy and align tactics accordingly
For more information please contact Sinéad Cullen on +353879500821 or [email protected]