Senior Centralized Monitoring Analyst

Role Overview

• 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

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.
• Strong attention to detail and skill with numbers
• Capable of applying strong knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations
• Demonstrated ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
• Strong analytical /problem-solving skills /judgment in decision making
• Ability to work productively with direct supervision
• 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
• 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

Benefits

• Professional development opportunities
• Remote work options