Senior Director, Head of Clinical Monitoring and Operational Systems

📋 Description

• Ensure that global clinical monitoring is conducted to the highest standards of quality and consistency.

• Supervise Lead CRAs while offering support and guidance for their management of monitoring teams.

• Improve the framework for clinical site monitoring and strategies for site management.

• Manage the Clinical Operations Systems team to enhance the development, efficiency, and integrity of the eTMF and CTMS systems.

• Responsible for reinforcing the monitoring, site management, and quality oversight strategy for clinical systems.

• Create standardized key performance indicators (KPIs) and key quality indicators (KQIs).

• Foster the growth and development of team members within the clinical monitoring and operations systems team.

• Represent the monitoring and clinical operations system functions in senior management meetings.

⛳️ Requirements

• Bachelor’s degree in a relevant discipline.

• At least 12 years of experience in the clinical trial industry, with a minimum of 5 years in onsite clinical monitoring.

• A minimum of 5 years providing oversight for global trial monitoring with direct management of monitors.

• Proven experience in managing FSP/CRO monitoring teams and developing monitoring quality metrics and KPIs.

• Demonstrated proficiency with various CTMS and eTMF platforms.

• Ability to be adaptable and serve as a role model.

• Competence in technical systems that enhance efficiencies (e.g., Power BI).

• Clear understanding of medical terminology and clinical trial processes.

• Extensive knowledge of ICH-GCP, FDA, EMA, and other international regulatory requirements.

• Proven attention to detail and ability to deliver effective presentations.

• Willingness to travel independently by air, car, and/or train.

🏝️ Benefits

• Annual bonus opportunity.

• Medical, dental, vision, life, and AD&D insurance.

• Short-term and long-term disability coverage.

• 401(K) plan with matching contributions.

• Stock options.

• Flexible non-accrual paid time off.

• Parental leave.