Clinical Operations Manager
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Job Description
Clinical Operations Manager leading clinical operations staff and monitoring quality for Indero, a dermatology-focused contract research organization. Driving compliant study execution, team development, and workflow innovation.
Responsibilities:
- Manage an assigned team of permanent and contracted Clinical Operations staff, including CRAs/cCRAs and Clinical Operations Support personnel
- Oversee staff performance and training, team resources, and project resource allocation
- Ensure clinical monitoring activities meet sponsor expectations, quality and timeliness requirements, budget, SOPs, regulations, good clinical practices, and study-specific requirements
- Implement professional development, coaching, mentoring, and performance evaluations
- Assist in developing and delivering Clinical Operations training
- Track operational metrics, site visits, utilization, deliverable timeliness, timesheets, expenses, and required training
- Perform Quality Assessment Visits with CRAs
- Identify quality issues through project meetings, site and team communications, reports, QAVs, and audit findings; establish corrective action plans
- Serve as a point of contact and management escalation contact for Clinical Operations personnel, sites, project teams, and sponsors
- Assess and interview potential Clinical Operations candidates
- Drive innovation, workflow optimization, efficiency, quality, scalability, and adoption of emerging technologies and AI-enabled solutions
- Foster innovation, collaboration, and proactive problem-solving across Clinical Operations teams
- Conduct on-site or remote monitoring visits as needed
- Review site visit reports and metrics, provide input on Clinical Operations plans and tools, and review related SOPs and tools
- Support site survey activities and synthesize insights for continuous improvement
- Perform other assigned responsibilities when appropriately experienced, qualified, and/or trained
Requirements:
- Experience and qualifications sufficient to manage assigned permanent and contracted Clinical Operations staff
- Knowledge of clinical monitoring activities and their execution in accordance with SOPs, regulations, good clinical practices, and study-specific requirements
- Ability to oversee performance objectives, remedial actions, professional development, and performance evaluations
- Ability to support training, coaching, mentoring, and consistent use of study tools and training materials
- Ability to track Clinical Operations metrics and monitor adherence to targets
- Ability to ensure monitoring expenses comply with policy and established guidelines
- Experience performing Quality Assessment Visits (QAV) with CRAs
- Ability to identify and address quality issues and establish corrective action plans
- Ability to serve as a management contact for sites, project teams, and sponsors
- Ability to assess and interview potential Clinical Operations candidates
- Ability to identify workflow optimization opportunities and support emerging technologies and AI-enabled solutions
- Required experience, qualifications, and/or adequate training for other assigned responsibilities
- Applicants must have a work permit for Spain
Benefits:
- Flexible work schedule
- Permanent full-time position
- Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
- Ongoing learning and development
- Attractive advancement opportunities
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