Director/Sr. Director, Global Clinical Operations
Reporting to the CMO, the Director/Sr Director of Global Clinical Operations will function in a strategic role, accountable for managing the overall execution of all clinical programs including but not limited to: Leading Clinical team in the management of clinical trials, managing external contractors, vendors, and CROs, and managing clinical timelines and budget. This position will work cross functionally to make operational and strategic decisions to support the achievement of clinical program objectives.
The candidate should have the experience and knowledge in trial management, site and vendor management and experience in study conduct from start to finish (start-up through close out).
Scope of Work & Responsibilities:
- Oversee all aspects of study level execution by the Clinical Operations Managers and Clinical Operations Associates, including but not limited to: Supervising site start-up and patient enrollment, clinical monitoring, compliance and data flow metrics from clinical sites, CROs and central labs.
- Drive leadership, oversight, and strategic/operational support of the Clinical Operations team.
- Hold accountability for and participate in long-range financial planning by working with Clinical Operations Managers and Finance to develop budgets, projections, accruals and track financial status against program-level budget
- Oversee the development and/or review of study documents (protocol, ICF, IB, monitoring plans, study manuals, eCRFs, IVRS, etc).
- Work with QA to develop internal Standard Operating Procedures required to ensure compliance with ICH GCP and federal regulations.
- Coordinate data analysis and presentations to ensure accuracy and timeliness.
- Oversee activities leading to internal GCP audits and regulatory inspections related to clinical trial conduct.
- Participate in request and review of scope of work, budgets, vendor performance and issue resolution.
- Provide direct management of Clinical Operations staff including hiring, resource planning, performance management, and regular coaching.
Qualifications and Professional Skills:
- Advanced or bachelor’s degree in related field.
- Minimum 10+ years of clinical operations and 8+ years management experience in an industry setting
- Familiar and comfortable with clinical operations concepts and operational practices and needs.
- Ability to lead study teams and manage multiple projects simultaneously.
- Prior experience in successfully managing and developing study documents, CROs, vendors, and other external partners.
- Excellent organizational and time management skills and ability to work independently.
- Experience in Oncology required, and experience with data management will be favorably considered.
- Demonstrated communication skills with the ability to clearly articulate timelines, deliverables and study questions/issues.
- Some travel required.
If you are interested in joining Ribon’s team, please email your resume to [email protected]