Clinical Operations Manager
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Job Description
Clinical Operations Manager overseeing teams, monitoring quality, training, and trial execution at Indero, a dermatology-focused contract research organization. Driving operational efficiency, compliance, and innovation across clinical studies.
Responsibilities:
- Manage an assigned team of permanent and contracted Clinical Operations staff
- Oversee staff performance, training, resources, and project allocation
- Ensure clinical monitoring activities deliver quality results on time and within budget
- Implement professional development, coaching, mentoring, and performance evaluations
- Develop and deliver training for Clinical Operations personnel
- Track operational metrics including site visits, utilization, deliverable timeliness, site visit reports, follow-up letters, timesheets, expenses, and training
- Perform Quality Assessment Visits with Clinical Research Associates
- Identify quality issues through project meetings, communications, reports, visits, and audits
- Summarize findings and establish corrective action plans
- Act as a management contact for escalated Clinical Operations and trial management issues
- Assist with candidate assessment and interviews
- Drive workflow optimization, efficiency, quality, scalability, and adoption of emerging technologies and AI-enabled solutions
- Foster innovation, collaboration, and proactive problem-solving
- Conduct on-site or remote monitoring visits as needed
- Review site visit reports and related metrics
- Review or provide input on Clinical Operations plans, tools, SOPs, and updates
- Support site survey activities and continuous improvement initiatives
- Undertake other responsibilities when qualified and adequately trained
Requirements:
- Day-to-day management of assigned permanent and contracted staff, including Clinical Research Associates (CRA)/(cCRA) and Clinical Operations Support personnel
- Ensure clinical monitoring activities meet sponsor satisfaction, timely quality deliverables, budget, SOPs, regulations, good clinical practices, and study-specific requirements
- Oversee direct reports, performance objectives, remedial actions, professional development, and performance evaluations
- Support training and development, including coaching and mentoring
- Ensure consistent use of study tools and training materials
- Track Clinical Operations metrics and adherence to targets
- Ensure monitoring expenses comply with policy and established guidelines
- Perform Quality Assessment Visits (QAV) with CRAs
- Identify clinical operations quality issues and establish corrective action plans
- Serve as a point of contact and management escalation contact for personnel, sites, project teams, and sponsors
- Assist with assessing and interviewing potential Clinical Operations candidates
- Identify required experience, qualifications, and/or training for other assigned responsibilities
- 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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