FSP Central Monitoring Operations Manager

Work Schedule

Environmental Conditions

Job Description

Summarized Purpose:

Identifies and characterizes issues and trends in operational and patient clinical trial data using analytical or statistical tools. Leverages operational experience and knowledge to evaluate issues and develop findings based on data analyzed to communicate issues and potential risks to project team members for follow-up action and participate in risk mitigation strategies.

What You'll Do:

• Accountable for site monitoring strategy and oversight, including authoring risk assessments and monitoring plans 
• Ensure effective sponsor oversight, trend analysis, and signal detection to support trial quality and delivery 
• Provide site monitoring expertise to the trial team and lead implementation of monitoring and oversight approaches 
• Oversee planning, execution, and issue management of site monitoring activities across all R/OPUs 
• Ensure compliance with protocol, ICH-GCP, regulatory requirements, and maintain inspection readiness 
• Safeguard patient safety, data integrity, and trial outcomes through effective monitoring oversight 

REQUIREMENTS

Education and Experience Requirements:

• University or comparable degree in life sciences or related field OR several years of equivalent professional education may be acceptable if complemented by solid knowledge in and experience with Site Monitoring and Site Management processes and accountabilities. 
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’).
• Strong Communication Skills: Demonstrates Accountability Agility Intrapreneurship (AAI) approach and skills in complex cross-functional matrix structures of the trial and extended team.
• Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action.
• Demonstrates active listening skills and cultural awareness.  
• Scientific and Operational Expertise: Demonstrates scientific and therapeutic knowledge and operational expertise across all Site Monitoring aspects in clinical trial planning and execution. Dimensions of trial complexity include protocol, patients, sites, countries, vendors. 
• Leadership and Influence: Demonstrates skills and capabilities in addressing complex situations, confidently coordinating and overseeing teams. Demonstrates leadership behaviors of supporting, connecting and empowering teams, setting priorities. 
• Good knowledge of English language and grammar