Centralized Monitoring Analyst I

Work Schedule

Environmental Conditions

Job Description

Join Us as a CM Analyst I Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.

As part of our expert team youll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Centralized Monitoring Analyst I you will identify and characterize issues and trends in operational and patient clinical trial data using analytical or statistical tools. You will leverage your operational experience and knowledge to evaluate issues and develop findings based on the data analyzed communicating issues and potential risks to project team members for follow-up action.

What Youll Do:
Reviews clinical trial data using a variety of tools and systems in alignment with the centralized monitoring plan with support from senior team members.
Characterizes and tracks the evidence of issues signals and potential risks with support from senior team members.
Ensures results of reviews are appropriately documented per department procedures.
May participate in development of risk characterization and reporting.
Supports review set-up including updating department database pulling reports etc.

Education and Experience Requirements:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 2 years). Prior experience in clinical monitoring data management biostatistics or related field in support of clinical trials is preferred.

In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills and Abilities:
Capable of applying fundamental knowledge and skills in a highly organized fashion while adhering to
regulatory guidelines global SOPs and client expectations
Strong attention to detail and skill with numbers
Good analytical /problem-solving skills /judgment in decision making
Ability to work productively with direct supervision
Ability to maintain a high degree of confidentiality with clinical data and clients proprietary data
Flexibility and adaptability
Ability to work in a team environment and independently
Good oral and written communication skills (English) with the ability to communicate with a variety of
internal customers including project team
Good computer skills with knowledge of MS Office (Word Excel PowerPoint) and the ability to learn
and use interactive computer systems
Ability to extract pertinent information from standard study documentation such as protocols
electronic study data systems with the ability to learn to identify trending of site/study data
Prioritization skills with ability to plan monitor and manage workload fluidly in response to changing
project demands
Satisfactory understanding of project protocol project documentation including Centralized
Monitoring Plan and other functional plans
Broad working knowledge of the roles functions and process of conducting clinical trials
Broad understanding of medical/therapeutic area knowledge and of medical terminology

Working Conditions and Environment:
Work is performed in an office/ laboratory and/or a clinical environment.
Exposure to biological fluids with potential exposure to infectious organisms.
Exposure to electrical office equipment.
Personal protective equipment required such as protective eyewear garments and gloves

Why Join Us

When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.