Director Clinical Trial Management

The University of Texas MD Anderson Cancer Center; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

A leading cancer center is seeking a Director of Clinical Trial Management to lead and oversee all aspects of clinical monitoring for trials. The successful candidate will drive strategy, manage teams, and ensure compliance with regulatory requirements, making significant contributions to advancing clinical development programs.

Qualifications

• 10 years of experience in clinical trial management, 5 years in leadership.
• Extensive experience managing multi-phase clinical trials.
• In-depth knowledge of ICH-GCP and FDA regulations.

Responsibilities

• Lead and oversee clinical monitoring aspects of trials.
• Develop scalable trial management strategies.
• Recruit and develop Clinical Trial Managers and CRAs.

Skills

Leadership

Strategic Thinking

Analytical Skills

Project Management

Communication

Problem Solving

Education

Bachelor’s degree in life sciences, nursing, pharmacy, or related field

Advanced degree (e.g., MSc, PhD, MBA) preferred

Job description

Job Title:Director Clinical Trial Management

Job Number: 36433

Location: Remote,

Job Description

The Director of Clinical Trial Management is responsible for leading and overseeing the clinical monitoring aspects of clinical trials from study design through closeout. This role ensures that trials are executed efficiently, on time, and in compliance with all regulatory requirements. The Director manages a team of Clinical Trial Managers (CTMs) and Clinical Research Associates (CRAs) and collaborates closely with cross-functional teams to achieve the strategic objectives of the clinical development programs.

Responsibilities

Leadership and Strategy:

• Develop and implement scalable clinical trial management strategies with a focus on technology-driven solutions and efficient resource planning.

• Provide leadership, direction, and oversight to the clinical trial management team, ensuring alignment with organizational goals.

• Foster effective communication and collaboration between internal functions and external partners throughout the trial lifecycle.

• Stay current with industry trends, regulatory requirements, and emerging best practices.

Trial Management:

• Build and maintain in-house clinical trial capabilities that are scalable, technology-enabled, and compliant with regulations.

• Develop flexible processes to support both in-house trial execution and outsourcing to Contract Research Organizations (CROs) as needed.

• Oversee the selection, contracting, and performance management of CROs and external vendors.

• Ensure all clinical trials adhere to ICH-GCP guidelines, FDA regulations, and other applicable requirements.

• Maintain high standards for patient safety, data integrity, and regulatory compliance.

• Support audit and inspection readiness and address any findings promptly.

Team Development and Management:

• Recruit, mentor, and develop CTMs and CRAs, fostering a culture of excellence and continuous learning.

• Conduct performance reviews, provide feedback, and support team members’ professional growth.

• Ensure team compliance with current SOPs, regulatory standards, and industry best practices.

Required Skills

• Bachelor’s degree in life sciences, nursing, pharmacy, or a related field (advanced degree preferred).

• Minimum of 10 years of experience in clinical trial management, with at least 5 years in a leadership role.

• Extensive experience managing multi-phase (I–IV) and multi-therapeutic area clinical trials.

• Background working within a sponsor company environment.

• Proven experience managing CRO partnerships and/or implementing integrated in-house clinical trial execution models (preferred).

• In-depth knowledge of ICH-GCP, FDA regulations, and global clinical trial guidelines.

• Strong strategic thinking, analytical, and project management skills.

• Demonstrated ability to lead and develop high-performing teams in a dynamic environment.

• Excellent communication, interpersonal, and problem-solving skills.

• Willingness to travel as needed (up to 25%).

• Preferred: Advanced degree (e.g., MSc, PhD, MBA) and experience with global clinical trials and regulatory submissions.