Provides strategic oversight, leadership and management of clinical trial execution, including oversight of site management and monitoring
Ensures 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).
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.
Participates in and/or leads departmental initiatives.
Conducts oversight visits at investigational sites to ensure quality monitoring.

Requirements

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.

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 US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and RayzeBio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, 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. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: T he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial executionsite managementmonitoringclinical site start-upGood Clinical Practices (GCP)study document developmentclinical operations managementoversight of CROclinical researchtimeliness and efficiency in operations

Soft Skills

leadershipstrategic oversightcollaborative relationshipscommunicationteam managementquality assuranceinitiative participationrelationship managementproblem-solvingtraining and mentoring