Clinical Operations Manager

This is a fully remote position, open to applicants in Spain.

📋 Description

• Manage a designated team of both permanent and contracted Clinical Operations personnel.

• Supervise staff performance, training, resource management, and project distribution.

• Ensure that clinical monitoring activities yield high-quality results promptly and within budget constraints.

• Implement professional development initiatives, coaching, mentoring, and performance evaluations.

• Create and deliver training programs for Clinical Operations staff.

• Monitor operational metrics such as site visits, utilization rates, deliverable timelines, site visit reports, follow-up correspondence, timesheets, expenses, and training.

• Conduct Quality Assessment Visits alongside Clinical Research Associates.

• Identify quality concerns through project meetings, communications, reports, visits, and audits.

• Compile findings and establish corrective action plans.

• Serve as a management point of contact for escalated Clinical Operations and trial management concerns.

• Assist with the evaluation and interviewing of candidates.

• Lead efforts to enhance workflow optimization, efficiency, quality, scalability, and the adoption of innovative technologies and AI-enabled solutions.

• Promote innovation, collaboration, and a proactive approach to problem-solving.

• Conduct on-site or remote monitoring visits as required.

• Review site visit reports and associated metrics.

• Review or provide input on Clinical Operations plans, tools, SOPs, and updates.

• Support site survey activities and initiatives geared towards continuous improvement.

• Take on additional responsibilities as qualified and trained.

⛳️ Requirements

• Daily management of assigned permanent and contracted personnel, including Clinical Research Associates (CRA)/(cCRA) and Clinical Operations Support staff.

• Ensure that clinical monitoring activities achieve sponsor satisfaction, timely delivery of quality outputs, adherence to budgets, SOPs, regulations, good clinical practices, and study-specific criteria.

• Supervise direct reports, set performance goals, implement remedial actions, support professional development, and carry out performance evaluations.

• Support training and development initiatives, including coaching and mentoring.

• Ensure the consistent application of study tools and training resources.

• Monitor Clinical Operations metrics and compliance with targets.

• Ensure monitoring expenses align with policies and established guidelines.

• Conduct Quality Assessment Visits (QAV) with Clinical Research Associates.

• Identify quality issues in clinical operations and develop corrective action plans.

• Act as a point of contact and escalation for personnel, sites, project teams, and sponsors.

• Assist in assessing and interviewing prospective Clinical Operations candidates.

• Determine the necessary experience, qualifications, and/or training for other assigned responsibilities.

• Must possess a work permit for Spain.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time employment.

• Comprehensive benefits package (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities).

• Continuous learning and development opportunities.

• Attractive opportunities for advancement.