CM Analyst I

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Thermo Fisher Scientific offers impactful work on a global scale. Join us in enabling our customers to improve health outcomes through research and development of life-changing therapies. With clinical trials in 100+ countries and innovative frameworks for clinical research, our work spans laboratory, digital, and decentralized clinical trial services.

Centralized Monitoring (CM) is a vital component of PPD's risk-based quality management (RBQM) strategy. Our team uses statistical and analytical tools, along with expertise from operationally experienced staff, to monitor and manage clinical study data. We prioritize critical risks to ensure data integrity and subject safety.

Summarized Purpose:

As a Centralized Monitoring Analyst I, you will analyze operational and patient clinical trial data using analytical or statistical tools. Your expertise will help identify and understand trends, and evaluate risks for communication to the project team.

Responsibilities

• Review clinical trial data using a variety of tools and systems in alignment with the centralized monitoring plan.
• Characterize and track evidence of issues, signals, and potential risks.
• Ensure results of reviews are appropriately recorded according to department procedures.
• May participate in the development of risk characterization and reporting.
• Support review set-up, including updating department databases and pulling reports.

Requirements

• Bachelor's degree or equivalent experience in a relevant academic or vocational field.
• Previous clinical trial experience (2+ years) in clinical monitoring, data management, biostatistics, or a related field supporting clinical trials.
• Strong attention to detail and numerical skills.
• Good analytical and problem-solving skills with sound judgment in decision-making.
• Ability to maintain confidentiality with clinical and proprietary data.
• Flexibility, adaptability, and capability to work both independently and within a team environment.
• Proficiency in MS Office (Word, Excel, PowerPoint) and capacity to learn and use interactive computer systems.
• Ability to extract pertinent information from standard study documentation and identify trending site/study data.
• Strong oral and written communication skills in English.
• Good understanding of project protocols, documentation, and medical terminology.
• Broad working knowledge of the roles, functions and processes of conducting clinical trials.

Working Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We encourage a healthy and balanced environment where you can thrive. You should be able to:

• Communicate and understand information with diverse groups.
• Work upright and stationary or standing for typical working hours.
• Lift and move objects up to 25 pounds.
• Work in non-traditional environments and use standard office equipment proficiently.
• Potentially be exposed to hazardous elements, including infectious agents, in healthcare or laboratory settings.
• Perform successfully under pressure while balancing multiple projects or activities.