Clinical Operations Manager

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

📋 Description

• Oversee a dedicated team of both permanent and contracted Clinical Operations personnel, including CRAs/cCRAs and Clinical Operations Support staff.

• Supervise team performance, training initiatives, resource management, and project resource distribution.

• Ensure that clinical monitoring activities align with sponsor expectations, maintain quality and timeliness, adhere to budget constraints, follow SOPs, comply with regulations, uphold good clinical practices, and fulfill study-specific requirements.

• Facilitate professional development through coaching, mentoring, and conducting performance evaluations.

• Assist in the creation and delivery of Clinical Operations training programs.

• Monitor operational metrics, including site visits, resource utilization, deliverable timelines, timesheets, expenses, and necessary training.

• Conduct Quality Assessment Visits alongside CRAs.

• Identify quality-related issues through project meetings, site and team communications, reports, QAVs, and audit outcomes; develop corrective action plans as necessary.

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

• Evaluate and interview prospective Clinical Operations candidates.

• Promote innovation, optimize workflows, enhance efficiency, ensure quality, and support the adoption of new technologies and AI-driven solutions.

• Encourage innovation, teamwork, and proactive problem-solving within Clinical Operations teams.

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

• Assess site visit reports and metrics, contribute to Clinical Operations planning and tools, and review associated SOPs and tools.

• Assist in site survey activities and consolidate insights for ongoing improvements.

• Undertake other assigned tasks as long as adequately experienced, qualified, and/or trained.

⛳️ Requirements

• Relevant experience and qualifications to manage both permanent and contracted Clinical Operations staff.

• Comprehensive understanding of clinical monitoring activities and their execution in alignment with SOPs, regulations, good clinical practices, and study-specific requirements.

• Capable of overseeing performance goals, implementing remedial actions, and facilitating professional development and evaluations.

• Ability to support training, coaching, mentoring, and the consistent application of study tools and materials.

• Competence in tracking Clinical Operations metrics and ensuring compliance with targets.

• Capability to ensure that monitoring expenses align with policy and established guidelines.

• Experience conducting Quality Assessment Visits (QAV) with CRAs.

• Skill in identifying and resolving quality issues and developing corrective action plans.

• Ability to serve as a management liaison for sites, project teams, and sponsors.

• Proficiency in assessing and interviewing potential Clinical Operations candidates.

• Aptitude for identifying opportunities for workflow optimization and supporting emerging technologies and AI solutions.

• Required experience, qualifications, and/or adequate training for additional assigned responsibilities.

• Candidates must possess a valid work permit for Spain.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

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

• Continuous learning and development opportunities.

• Attractive prospects for career advancement.