Sr CM Analyst II

Work Schedule

Environmental Conditions

Job Description

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 Senior CM Analyst II 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.

You will begin to develop a data analytics specialization and may execute data analytics lead tasks or function as the lead on projects.

• Independently review and analyze clinical trial data using a variety of tools and systems in alignment with the centralized monitoring plan
• Flex review assignments across the majority of different analyses
• Characterize and track evidence of issues signals and potential risks
• Perform complex analyses and root cause analyses to connect related signals to risks
• Ensure delivery of high-quality on-time results

• Participate in lead activities such as:
  • Contribution to the development of the Centralized Monitoring Plan
  • Department risk assessment tool
  • Cross-functional risk assessment meetings
  • Risk reports
  • Generating findings reports following review cycles
• May function as the data analytics lead on some projects

• Communicate issues and potential risks to project team members for follow-up action
• Provide training and guidance to junior team members
• Work collaboratively across multidisciplinary teams

• 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 5 years
• Prior experience in:
  • Clinical monitoring
  • Data management
  • Biostatistics
  • Related field in support of clinical trials 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.

Strong knowledge and skills while adhering to:

• Regulatory guidelines
• Global SOPs
• Client expectations

Strong attention to detail and numerical skills
Strong analytical and problem-solving skills
Sound judgment and decision-making abilities
Ability to work productively with direct supervision
High level of confidentiality with clinical and proprietary client data
Demonstrated flexibility and adaptability
Ability to work independently and within a team environment

• MS Office:
  • Word
  • Excel
  • PowerPoint
• Interactive computer systems

• Extract pertinent information from:
  • Protocols
  • Electronic study data systems
  • Study documentation
• Identify trends in site/study data

Strong prioritization and workload management skills
Ability to adapt to changing project demands
Strong understanding of:

• Project protocols
• Project documentation
• Centralized Monitoring Plans
• Functional plans

• Work is performed in an office environment with exposure to electrical office equipment
• Occasional drives to site locations with occasional travel both domestic and international

When you join Thermo Fisher Scientific you become part of a global team that values:

• Passion
• Innovation
• Commitment to scientific excellence

Youll work in an environment where collaboration and development are part of the everyday experience and where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.