Sr CM Analyst I

Position Overview

• Company: Thermo Fisher Scientific Inc.
• Location Type: Onsite
• Job Type: Full Time
• Salary: Not specified

Thermo Fisher Scientific is dedicated to making the world healthier, cleaner, and safer. This role within Centralized Monitoring (CM) is a pivotal position in advancing global health initiatives through clinical research. CM is an integral part of PPD’s risk-based quality management (RBQM) strategy, focusing on risk surveillance and centralized statistical monitoring to ensure data quality and subject safety.

Requirements

• Education: Bachelor’s degree or equivalent relevant formal academic/vocational qualification.
• Experience: At least 5 years of experience in clinical monitoring, data management, biostatistics, or a related field supporting clinical trials.
• Compliance: Strong organizational skills with adherence to regulatory guidelines and global SOPs.

Responsibilities

• Serve as the Centralized Monitoring functional lead, possessing knowledge of RBQM methodologies, tools, and processes.
• Lead activities such as developing centralized monitoring plans and generating findings reports.
• Manage review timelines and support budget management.
• Serve as a functional representative, communicating and working with the study team.
• Ensure reviews are complete, generate reports, and lead Centralized Monitoring Review meetings to discuss issues and risks with the study team.
• Contribute to risk assessment through department risk assessment tools and participate in cross-functional risk assessment review meetings.
• Characterize and track evidence of issues, signals, and potential risks.
• Provide training and mentorship to junior team members.

Knowledge, Skills, and Abilities

• Proven analytical and problem-solving abilities.
• Outstanding attention to detail and numerical skills.
• Solid oral and written communication skills.
• Proficiency with MS Office and interactive computer systems.
• Ability to extract pertinent information from standard study documentation.
• Ability to work independently and within a team environment.

Working Environment

• Physical Requirements:
  • Ability to communicate effectively with diverse groups.
  • Ability to work upright, stationary, and/or standing for typical working hours.
  • Ability to lift and move objects up to 25 pounds.
  • Ability to work in non-traditional environments.
  • Ability to use and learn standard office equipment and technology proficiently.
  • Ability to perform under pressure while prioritizing multiple projects.

Application Instructions

• Interested candidates should visit the Thermo Fisher Scientific careers website to submit their application.