What are the responsibilities and job description for the Associate Director, Clinical Operations Process Excellence position at HW3?
Associate Director, Clinical Operations Process Excellence
We’re seeking a Clinical Operations professional to help build a new Process Excellence function from the ground up. This role combines strategic process leadership with hands-on project execution — focused on SOP development, training, inspection readiness, and cross-functional alignment.
Key Responsibilities:
- Develop and maintain SOPs, standards, and the Clinical Ops Toolkit
- Deliver onboarding, training, and process rollout across teams
- Lead KPI tracking and reporting to support operational improvements
- Act as audit/inspection lead in partnership with Quality Assurance
- Drive cross-functional process improvement projects
- Lead post-study reviews and support continuous improvement
What We’re Looking For:
- 5–8 years in Clinical Operations or Clinical Research (global studies, oncology/rare disease a plus)
- Strong knowledge of GCP, ICH, FDA/global regulations
- Experience with SOPs, training, process improvement, and KPI tracking
- Excellent project leadership and communication skills
- Proficiency with Smartsheet, Excel, and reporting tools
- PMP certification and audit/inspection readiness experience preferred
If this role matches your skills and career goals, we’d love to hear from you! Apply today.
