Location: Remote
Job Summary
The Sr. Manager, Clinical Program Management is responsible for the oversight, planning and delivery of assigned clinical study(ies) within the RayzeBio programs, including oversight and management of the study Clinical Research Organization (CRO) and Vendors according to and in compliance with corporate and program Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other applicable federal (FDA) and state regulations, in order to achieve established study goals within timelines and budget and of the highest quality.
Job Responsibilities:
Essential duties and responsibilities include the following. Other duties may be assigned.
- Manage global clinical study teams, CROs and vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with RayzeBio SOPs, FDA regulations and ICH/GCP guidelines
- Leads the cross-functional study execution team in achieving the study goals and deliverables
- Plan and execute study timelines
- Develop and manage risk mitigation strategies for clinical studies
- Tracks, monitors and reports on study progress and proactively escalates issues to key internal stakeholders to ensure timely resolution of issues
- Manage study CRO and vendor budgets and invoicing procedures according to study contract
- Perform oversight review and quality control of CRO and vendor scope of activities, ensuring compliance to key performance metrics and overall inspection readiness
- Active participant in CRO and vendor meetings, responsible to review key CRO and vendor study operational plans and provides input to operational strategy, including country and site feasibility and start-up
- Summarizes CRO and vendor performance data and escalates study risks to the Head of Clinical Operations
- Performs other related duties as assigned
- Up to 20% travel required
Education and Experience:
- Minimum 5-7 years clinical operations experience within biotech, pharma or CRO industry
- BA/BS degree, scientific or healthcare discipline preferred
Skills and Qualifications:
- Independent professional who proactively communicates frequently and effectively.
- Detail and action-oriented, organized and committed to quality and consistency.
- Ability to work successfully in cross-functional teams.
- Ability to work in a dynamic environment with a high degree of flexibility.
- Expertise in Microsoft Project and Smartsheets desired.
The starting compensation for this job is a range from $142,000-$193,000.00 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
Please click here to apply.
