FSP Central Monitoring Operations Manager

Responsibilities

The manager is responsible for overseeing site monitoring strategies, conducting risk assessments, and ensuring trial quality through trend analysis and signal detection. They lead cross-functional teams to maintain regulatory compliance, patient safety, and data integrity across clinical trials.

Requirements

Candidates must hold a university degree in life sciences or equivalent professional experience, with at least 3 years of experience in site monitoring and management. Strong leadership, communication, and operational expertise in complex clinical trial environments are required.

Skills

• Site Monitoring
• Risk Assessment
• Trend Analysis
• Signal Detection
• Clinical Trial Management
• Data Integrity
• Regulatory Compliance
• ICH-GCP
• Issue Management
• Cross-functional Leadership
• Strategic Planning
• Communication Skills
• Active Listening
• Cultural Awareness
• Scientific Knowledge
• Operational Expertise

About this role

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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

About Thermo Fisher Scientific

Biotechnology Research · 10,001+ employees · headquartered in Waltham, MA