Clinical Operations Manager

Job Overview

Oversee daily line management of clinical administration teams, ensuring operational excellence, resourcing, training, and professional development. Collaborate with senior management on strategic planning and business development, focusing on performance management and adherence to procedures.

Responsibilities

• Lead day-to-day management of clinical administration team members, providing coaching, development support, resourcing, alignment, training, and ongoing professional development.
• Analyze performance metrics and provide feedback to enhance individual and team performance.
• Develop and implement Working Practice Documents (WPDs), Standard Operating Procedures (SOPs), and training processes for clinical administration and staff, including project-specific training and mentoring.
• Act as a point-of-escalation for performance concerns and training needs to ensure adherence to SOPs and WPDs.
• Collaborate with leadership on resourcing needs and perform other duties as assigned.

Qualifications

• Bachelor’s degree or equivalent relevant formal academic/vocational qualification.
• Significant clinical research experience (5+ years), including remote and clinical monitoring across all phases of study life cycle.
• 1+ year of leadership responsibility.
• Advanced knowledge of ICH GCP, applicable regulations, and procedural documents.
• Extensive experience in TMF management or clinical operations within the clinical research industry.
• Proficiency in electronic TMF systems and document/data management tools, with focus on audit readiness.
• Advanced knowledge of all phases of clinical trials, particularly study start-up, maintenance, and close-out.
• Advanced skills in managing, motivating, and mentoring staff.
• Strong knowledge of budgets, projects, and metrics; ability to handle multiple tasks, meet timelines, and work in stressful situations.
• Excellent organization, attention to detail, communication, and interpersonal skills.
• Ability to travel if required.