Associate Director/Director, Clinical Site Operations

Location: Remote

Summary

The Associate Director/Director, Clinical Site Operations provides strategic oversight, leadership and management of clinical trial execution, including oversight of site management and monitoring, consistent with RayzeBio   corporate goals and program Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other applicable federal (FDA) and state regulations. The Associate Director/Director, Clinical Site Operations will also ensure that such operations activities    are timely, efficient, and of the highest quality.

Job Responsibilities

Essential duties and responsibilities include the following.  Other duties may be assigned.

  • Directs the operational oversight and execution of clinical site start-up, management and monitoring in accordance with RayzeBio SOPs, ICH Guidelines, and Good Clinical Practices (GCP) to ensure overall data quality, integrity, and patient protection and safety
  • Manages CRO relationship and oversight to ensure the appropriate scope of work, oversight and training of the clinical team, investigators and site staff as well as the achievement of study milestones within agreed upon timelines and budget
  • Develops collaborative relationships with investigative sites
  • Communicates clinical site performance data to the Head of Clinical Operations and the Clinical Program Management team
  • Key contributor to the development, review and approval of study documents including but not limited to RayzeBio SOPs and Clinical Operation Plans.
  • Liaison with other functional departments to ensure that the highest quality is maintained
  • Participate in and/or lead departmental initiatives
  • Line management skills and expertise in mentoring and coaching
  • Detail oriented, organized and committed to quality and consistency
  • Excellent team-interaction skills and ability to work successfully in cross-functional teams
  • Ability to work in a dynamic environment with a high degree of flexibility
  • Represent RayzeBio at conferences as well as scientific and other business-related meetings as required
  • Assists in creating vision for department goals and objectives
  • Conduct oversight visits at investigational sites to ensure quality monitoring
  • Up to 20% travel required

Education and Experience

  • Minimum 10 years clinical operations experience within biotech, pharma or CRO industry
  • Proven experience in clinical research as team lead in clinical functions
  • BA/BS degree, scientific or healthcare discipline preferred

Skills and Qualifications

  • Independent professional who proactively communicates frequently and effectively.
  • Organized and able to work on multiple projects with tight deadlines.
  • High energy level; positive attitude; works well under stress; assertive and effective communicator.
  • Hands-on, action-oriented, and able to implement effectively.

Physical Demands

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision and distance vision. 

Work Environment

The noise level in the work environment is usually moderate.

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