Senior Centralized Monitoring Analyst

Thermo Fisher Scientific India Pvt Ltd; Bengaluru; On-site; INR 1,000,000 - 1,500,000; Full time

Job summary

Thermo Fisher Scientific India Pvt Ltd is seeking a Senior CM Analyst I to identify and characterize issues in clinical trial data, using analytical tools to evaluate incidents and risks. The role may lead data analytics on projects and provide guidance to junior team members.

You will operate within a centralized monitoring framework, ensuring timely, high-quality results while maintaining confidentiality and regulatory compliance.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic qualification.
• 5+ years of experience in a role with knowledge to perform the job.
• Prior experience in clinical monitoring, data management, biostatistics or related field in support of clinical trials is preferred.

Responsibilities

• Independently reviews and analyzes clinical trial data using tools in alignment with the centralized monitoring plan.
• Characterizes and tracks the evidence of issues, signals and potential risks.
• Performs complex analyses and root cause analyses to connect related signal to risks and ensure delivery of high-quality results.
• May participate in lead activities such as development of the centralized monitoring plan and risk assessment meetings.
• May function as the data analytics lead on some projects.

Skills

CluePoints experience

Data analysis

Clinical trials

Regulatory compliance

MS Office

Communication skills

Education

Bachelor's degree or equivalent

Tools

MS Excel

PowerPoint

Job description

Sr Centralized Monitoring Analyst - (CluePoints Experience Preferred) Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description

Join Us as a Senior 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 2,700 clinical trials across 100+ countries in the last 5 years. As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Senior CM 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. You will begin to develop a data analytics specialization and may execute data analytics lead tasks or function as the lead on projects.

What You’ll Do:

• Independently reviews and analyzes clinical trial data using a variety of tools and systems in alignment with the centralized monitoring plan, flexing review assignments across the majority of different analyses.
• Characterizes and tracks the evidence of issues, signals and potential risks.
• Performs complex analyses and root cause analyses to connect related signal to risks, and responsible for ensuring delivery of high-quality, on time results.
• May participate in lead activities, such as contribution to the development of the centralized monitoring plan, department risk assessment tool and cross-functional risk assessment meetings, risk reports and generating findings reports following review cycles.
• May function as the data analytics lead on some projects.
• Provides training and guidance to junior team members.

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 5+ 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 strong 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
• Strong analytical /problem-solving skills /judgment in decision making
• Ability to work productively with direct supervision
• Demonstrated ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
• Demonstrated flexibility and adaptability
• Ability to work in a team environment and independently
• Solid oral and written communication skills (English) with the ability to communicate effectively with a variety of internal and external customers, including project team, functional management and client contacts
• Solid computer skills, with good knowledge of MS Office (Word, Excel, PowerPoint) and the ability to learn and use interactive computer systems
• Using CluePoints is preferred.
• Comprehensive ability to extract pertinent information from standard study documentation, such as protocols, electronic study data systems and to identify trending of site/study data
• Firm prioritization skills with ability to plan, monitor and manage workload fluidly in response to changing project demands
• Strong understanding of project protocol, project documentation including Centralized Monitoring Plan and other functional plans

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

Experience Level Senior Level