Senior Centralized Monitoring Analyst I
Senior Centralized Monitoring Analyst I
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Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific Inc. our mission is to make the world healthier cleaner and safer. As a Sr CM Analyst I you will play a pivotal role in advancing global health initiatives through worldclass clinical research. Our collaborative environment dedication to excellence and brandnew resources will empower you to excel and make a global impact.
Centralized Monitoring (CM) is an integral part of PPDs riskbased quality management (RBQM) strategy. We deliver risk surveillance and centralized statistical monitoring combining the power of statistical and analytical tools with expertise from operationally experienced staff to monitor and manage clinical study data. Ongoing data assessments from our Centralized Monitoring group facilitates dynamic adaptation of monitoring plans with a focus on criticaltoquality risks that drive data quality and have the greatest impact on data integrity and subject safety.
Job Responsibilities
Serve as the Centralized Monitoring functional lead with knowledge in 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 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 crossfunctional risk assessment review meetings.
Characterize and track evidence of issues signals and potential risks.
Provide training and mentorship to junior team members.
Education and Experience
Bachelors degree or equivalent relevant formal academic/vocational qualification.
At least 5 years of experience in clinical monitoring data management biostatistics or a related field in support of clinical trials.
Equivalent combinations of education training and/or directly related experience will be considered.
Knowledge Skills and Abilities
Strong organizational skills with adherence to regulatory guidelines and global SOPs.
Outstanding attention to detail and numerical skills.
Proven analytical and problemsolving abilities.
Ability to work independently and within a team environment.
Solid oral and written communication skills.
Proficiency with MS Office and interactive computer systems.
Ability to extract pertinent information from standard study documentation.
Working Environment
Thermo Fisher Scientific values the health and wellbeing of our employees and encourages a balanced environment. You must be able to:
Communicate effectively with diverse groups.
Work upright stationary and/or standing for typical working hours.
Lift and move objects up to 25 pounds.
Work in nontraditional environments.
Use and learn standard office equipment and technology proficiently.
Perform under pressure while prioritizing multiple projects.
Required Experience:
Senior IC
Employment Type
Full-Time
