Senior Clinical Trials Manager

About Company

Company 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. Our initial focus is on 505(b)(2) products that we believe may improve the standard of care. Our product pipeline includes wholly owned development candidates. Our lead product candidate, 234, is in clinical testing for the treatment of pulmonary arterial hypertension (PAH) and the first of its kind for use on an as-needed basis (PRN). We anticipate launching additional product development programs into our pipeline in 2023.

The environment at is fast-paced and highly focused. Honesty, kindness, and treating all colleagues as equals are key descriptions of the Company environment. The company appreciates the work-place changes brought about by the Covid Pandemic, and we strive to continue to allow flexible and adaptive work structures within the context of our demanding development timelines.

Position Description

• Manage end-to-end clinical contracts between external service providers (ESP) and internally at
  
  
  
  • 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 electronic training port al
  
  
  
  


• Sole management of GCP training matrix for Clinical Depart ment
  
  
  
  • 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 Clinical Operations
  
  
  
  


• Sole manager and curator of biological samples from clinical trials with approved external reference labs
  
  
  
  • Responsible for liaising with external pa ies 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 Sma Sheets, One-Pager Pro, Medrio and Oracle clinical databases