Location: Remote
Summary
The Clinical Program Manager contributes to the oversight, planning and delivery of assigned clinical study(ies) within the RayzeBio programs. This includes oversight and management of the study Clinical Research Organization (CRO) and Vendors according to and in compliance with corporate and project/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. This role will support the Sr. Director, Clinical Program Management and other Clinical Program Managers in Clinical Operations in the overall planning, monitoring and reporting of all clinical studies within the assigned RayzeBio clinical program(s).
Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
- Coordinates and contributes to the review of relevant study plans and documents including informed consent forms, project management and monitoring plans, vendor study documents
- Supports the clinical program lead/manager in the oversight and management of study CROs to ensure that the study(ies) are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
- Responsible for management of select study vendors including review of vendor study operational plans, key performance metrics, risks identification and mitigation and proactively escalates issues to the clinical program lead to ensure timely resolution of issues and overall inspection readiness
- Active participant in CRO and vendor meetings and study execution meetings
- Supports the clinical program lead/manager in planning and maintaining study timelines, ensuring the cross functional project team remains on track for project and study deliverables
- Tracks, monitors and reports on study progress
- Manages study CRO and vendor budgets and invoicing procedures according to study contract
- Summarizes CRO and vendor performance data and escalates risk to the Clinical Operations Program Lead and/or Head of Clinical Operations, as needed
- 20% of travel required
Education and Experience
- BS/BA in relevant discipline
- 6+ years of experience in Clinical Operations
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
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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