Remote Associate Director Clinical Trials Operations

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