Senior Manager, Clinical Trial Management - Remote

Overview

The Senior Manager Clinical Trial Management (Sr. MCTM) offers an additional development path for clinical research professionals. Responsibilities focus on the management and career development of the organization’s Clinical Trial Managers (CTM, Sr. CTM, Principal Clinical Trial Managers (PCTM) and MCTMs, as well as supporting the development of departmental initiatives to strengthen the quality and productivity of Clinical Trial Management operations.

In Short

• Develop, mentor, coach and manage CTMs, PCTMs and MCTMs.
• Ensure studies are conducted in accordance with applicable SOPs, regulations, and ICH GCP principles.
• Provide leadership and oversight on clinical programs.
• Collaborate with the Resourcing team to ensure Clinical Operations resource allocations and needs are appropriately met.
• Generate action plans and provide developmental/strategic oversight to optimize CTM services.
• Provide ongoing feedback and development to manage the performance of direct reports.
• Ensure all assigned CTMs have the proper resources, training, materials, and access to systems.
• Identify quality risks and recommend corrective action plans.
• Interact with Project Manager and/or Director of Project Management in the escalation and resolution of clinical study issues.
• Develop and revise Clinical Operations SOPs, work instructions, forms, and templates.

Requirements

• Graduate degree in a scientific or health-related field.
• 10 years of industry experience in clinical research.
• 5 years direct supervisory/line management experience in clinical research.
• Working knowledge of ICH GCP guidelines and the clinical development process.
• Excellent communication and interpersonal skills.
• Excellent organizational skills and attention to detail.
• Ability to travel domestically and internationally.

Benefits

• Opportunities for career advancement.
• Supportive work environment focused on quality and performance.
• Engagement in departmental initiatives.
• Development of skills and competencies.