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Sr. Manager / Associate Director Clinical Development Operations

 Remote but preference is East Coast

Report to:
Sr. Vice President, Clinical Development Operations (CDO)

 About Company 

Company (“RTX”) is a clinical-phase company.  Our core technology combines proprietary dry-powder inhaler device technologies and advanced particle engineering-based inhaled drug formulation approaches to develop novel therapeutics that deliver the drug more directly to the lung and lung periphery, instead of in the oropharyngeal cavity. 

Position Description

  • Manage end-to-end clinical contracts between external service providers (ESP) and internally at “RTX”
    • Responsible for invoice review and adjudication with ESP
    • Lead role in annual budget projections for current and new ESP
    • Identify new ESPs as necessary
  • Working with clinical development team colleagues, create and maintain internal clinical trial timelines and study-specific work plans using internal templates
    • Prospectively identify gaps and constraints and prosecute findings with clinical development team
  • Responsible for set up with ESP and logistics on all clinical trial shipments to and from research sites
  • Subject matter expert (SME) on device malfunction tracking, reporting, and remediation re-education at site and ESP levels
    • Provide and deliver remediation training within context of internal standards and review
  • Work with clinical development and clinical operations teams to create SME training as needed for clinical study conduct
    • SME for “RTX” electronic training portal
  • Sole management of GCP training matrix for Clinical Department
    • Work with QA to identify training gaps and procure method for gap training
    • Responsible for organizing and providing annual company wide GCP training in collaboration with Heads of QA and CDO
  • Sole “RTX” manager and curator of biological samples from clinical trials with approved external reference labs
    • Responsible for liaising with external parties ensuring on-time analysis and data transfers
  • Core NDA preparation team member
    • Key planning role
    • Provide information for sections
    • Coordinate timing and quality of deliverables from ESPs

 

Candidate Profile

  • Internally motivated to deliver high-quality work products on time and within budget
  • Excellent communication and planning skills
  • Ability to recognize personal information gaps and seek advice and counsel of internal associates and engage in appropriate self-study
  • Thrives on learning new aspects of clinical development work and integrating these with current expertise
  • Able to prioritize multi-faceted role against dynamic timelines and rapidly changing corporate needs
  • Working knowledge of ICH GCP
  • Minimum of 7 years working in clinical development and/or clinical operations roles at a biopharma or clinical contract research organization with a minimum of 4 years in a management capacity
  • Advanced working knowledge of Microsoft Excel, PowerPoint, and Project
  • Bonus: working experience using Smart Sheets®, One-Pager Pro™, Medrio and Oracle clinical databases

 

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