[Hiring] Director, Clinical Site Operations @Bristol Myers Squibb
Role Description
The 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 Director, Clinical Site Operations will also ensure that such operations activities are timely, efficient, and of the highest quality.
• 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
Qualifications
• 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
Requirements
• 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
Benefits
• Health Coverage: Medical, pharmacy, dental, and vision care
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP)
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support
• Work-life benefits include Paid Time Off
• Flexible time off (unlimited, with manager approval, 11 paid national holidays)
• Additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Years Day
Apply Now
Apply Now
The 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 Director, Clinical Site Operations will also ensure that such operations activities are timely, efficient, and of the highest quality.
• 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
Qualifications
• 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
Requirements
• 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
Benefits
• Health Coverage: Medical, pharmacy, dental, and vision care
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP)
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support
• Work-life benefits include Paid Time Off
• Flexible time off (unlimited, with manager approval, 11 paid national holidays)
• Additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Years Day
Apply Now
Apply Now