Centralized Monitoring (CM) Analyst I

Job Description

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.   

PPD's Centralized Monitoring group delivers a new approach to 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. Centralized Monitoring staff explores study data holistically to pinpoint meaningful signals, resulting in more efficient and effective issue resolution and a proactive approach to risk detection. Using this data-driven approach, PPD can address study problems or site performance quickly, directing remediation activities where needed and positioning on-site monitoring activity in a targeted approach.

Centralized Monitoring is an integral part of PPD’s risk-based monitoring (RBM) strategy and supports centralized monitoring efforts. Ongoing data assessments from our Centralized Monitoring group allows to adapt monitoring plans dynamically so that CRAs can focus on the factors that have the greatest impact on data integrity and subject safety. Regardless of the percentage of source data verification (SDV), the Centralized Monitoring group's centralized statistical monitoring approach identifies risk signals that may be difficult to detect through traditional review methods, such as on-site monitoring.

Centralized Monitoring evaluates data within and across studies, sites, countries and regions.

Our analytic approach provides insight into:

• Data errors, deviations
• Trends, outliers
• Unusual variation (or lack of variation)
• Potential data manipulation, fraud
• Other systematic errors or data integrity issues.

As a Centralized Monitoring (CM) Analyst, you’ll be supporting centralized statistical and risk surveillance activities on assigned trials. The CM Analyst will identify and characterize issues and trends in operational and patient clinical trial data using analytical or statistical tools. The role will leverage operational experience and knowledge to evaluate issues and develop findings based on data analyzed to communicate issues and potential risks to project team members for follow-up action.

Essential Functions: 

• 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:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience in clinical monitoring, data management, biostatistics or related field that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).

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 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

About us:

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!http://jobs.thermofisher.com