Senior Director Clinical Operations

Senior Director, Clinical Operations

Contract to Perm

Position Description

Primary Responsibility

• Manage end-to-end enrollment process between research sites and Company
  
  
  
  • Responsible for collection and review of screen data in a time-sensitive fashion that does not prolong the screening process
  
  
  • Liaise with Company Medical personnel to review screen data and ensure per-protocol enrollment of study subjects
  
  
  • Write and issue protocol exemptions as determined necessary by Company Medical personnel
    
    
    
    • Responsible for documentation management with sites, CRO,s and Sponsor Personnel
    
    
    
    
  
  
  
  

• Subject matter expert (SME) on patient status tracking
  
  
  
  • Able to create functional spreadsheet(s) to track key information on potential patients
  
  
  • Provide metrics from tracking
  
  
  • Use tracking to follow-through on all potential subjects until enrolled or no longer interested
  
  
  
  


• Work with clinical development and clinical operations teams to create SME training as needed for at-site patient identification and enrollment


• Work with CRAs and Clinical Trial Specialists to ensure timely, efficient enrollment and work with CRAs on medical data entry issues at the site level

Additional Responsibilities

• Additional drug development roles will be added as time is available and commensurate with the incumbents interests, such as, but not restricted to:
  
  
  
  • Attending and sharing approved information about Company studies at medical congresses
  
  
  • Coordination with patient advocacy groups
  
  
  • Review of patient identification processes at research sites and provide remediation on process as appropriate
  
  
  • Perform medical/clinical review on: data listings, regulatory reports, CSRs, etc.
    
    
    
  
  
  
  

Candidate Profile

• RN, FNP, PA degree required. Prior nursing or physician assistant experience in Cardiovascular and/or Cardiopulmonary interventions and patient treatment is mandatory
  
  
  
  • Minimum 5 years of clinic and/or hospital setting as a health care provider
  
  
  • Minimum of 2 years functioning in a management capacity
  
  
  
  


• Minimum of 2 years in a similar role for a Pharmaceutical company or CRO


• Internally motivated to deliver high-quality work products on time and within budget


• Excellent communication and planning skills


• Able to prioritize multi-faceted role against dynamic timelines and rapidly changing corporate needs


• Working knowledge of ICH GCP