The Director, Clinical Operations position, will report to the Chief Medical officer and will provide overall leadership for NanoString Clinical Operations group including hiring, mentoring, professional development and performance management of the staff, as well as oversight for execution of clinical programs including timelines, budgets, resources, clinical trial sites, vendors and key project deliverables. The position includes responsibility for continuous improvement of scalable and rigorous department infrastructure and processes through the development of SOPs, guidelines and the use of technology, which will be critical to the success of NanoString Clinical Programs, including multiple CDx activities.
- Provide clinical operations leadership and perspective in defining NanoString Clinical Operations group and overseeing its processes and execution of clinical study programs, including multiple CDx activities.
- Hire, supervise and train operations personnel as appropriate and assume ownership of the quality of clinical programs and deliverables.
- Set annual goals, objectives and development plans for staff, provide performance feedback and conduct performance evaluations
- Ensure operational feasibility of clinical development plans and scenarios, including timeline, budget and resource requirements. Ensure all study activities are completed in accordance with ICH GCP, health authority regulations and SOPs.
- Lead strategic discussions regarding program and study resourcing, including outsourcing requirements at the study, program, and corporate levels.
- Guide study team in vendor selection and provide management oversight throughout the life of all assigned clinical projects. Proposes vendors for approval.
- Determine operational feasibility and implementation path of the study/program objectives; manages and communicates to senior management and key stakeholders.
- Work with other project team leaders to review the study documents including clinical trial protocol, amendment, informed consent form, case report forms, investigator brochure, site and third party vendor contracts, clinical study reports, etc.
- Partner with other project team members in managing relationship with corporate partners on studies/programs, as applicable, for clinical operations.
- Identify and provide solutions and direction related to key cross-functional, sponsor-site, and sponsor-CRO clinical trial issues.
- Develop, implement and maintain standards across clinical programs to ensure scalability and rigor of NanoString Clinical Operations.