Sr Centralized Monitoring Analyst - (CluePoints Experience Preferred)

Overview

Senior CM Analyst I role supporting centralized monitoring of clinical trials, identifying and characterizing issues, signals and risks in operational and patient clinical trial data.

What you'll do

• Independently review and analyze 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.
• Characterize and track the evidence of issues, signals and potential risks.
• Perform complex analyses and root cause analyses to connect related signals to risks, and ensure delivery of high-quality, on-time results.
• May participate in lead activities, such as contributing to the development of the centralized monitoring plan, department risk assessment tool and cross-functional risk assessment meetings, risk reports and findings reports following review cycles.
• May function as the data analytics lead on some projects.
• Provide training and guidance to junior team members.

What you'll need

• 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).
• 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 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.
• Comprehensive ability to extract pertinent information from standard study documentation, such as protocols and 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 and project documentation, including the Centralized Monitoring Plan and other functional plans.

Nice to have

• Prior experience in clinical monitoring, data management, biostatistics or related field in support of clinical trials.
• Using CluePoints.

Details

• Location: Bengaluru, India.
• Work schedule: Standard (Mon-Fri).
• Environmental conditions: Office.