Centralized Monitoring Analyst 1 (Thermofisher)

Roles and Responsibilities

What You’ll 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.

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 client's 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

Education and Experience Requirements:
• Bachelor's 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.
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