Central Monitor/Sr. Central Monitor
Alto Neuroscience
Mountain View, CA, USA
Posted on Sep 12, 2024
Primary Responsibilities
- Centrally reviews clinical data at aggregate level, using analytic tools to support the identification of protocol deviations, risks and unusual data patterns/trends
- Reviews clinical and external data for subjects enrolled in clinical research protocols based on functional plans for completeness, accuracy and consistency
- Identifies and generates queries for missing, inconsistent, or out-of-range data, works with the Clinical Research Associate (CRA) and/or site to resolve the issues
- Mitigates risks by using signal detection and quality indicators and assists to identify sites which may require more monitoring based on risk assessment and data trends
- Communicates and triages issues to appropriate roles for follow-up and action to address root cause
- Creates analytic outputs and presentations to facilitate data reviews and to support data-driven decision-making
- Supports activities related to the development of the electronic data capture (EDC) system
- Contributes to the development and maintenance of study documents specifying central monitoring strategy, approach and procedures on assigned protocols/projects
- Provides input to applications, databases and systems used to monitor study data
- Reviews study protocols and leads or supports the clinical data review activities associated with a clinical study and the delivery of data fit for analysis
- Leads the development of the clinical monitoring plan and contributes to the development of the data management plan
- Collaborate with Clinical Trial Managers/Clinical Project Managers and Clinical Research Associates to ensure they are well equipped with the details of site related risk/issue(s) to plan timely site intervention (site visits or telephonic contacts with sites) and to ensure more efficient and focused activities during monitoring visits
- Continuous evaluation of and improvement of monitoring processes based on feedback, data analysis and changes in regulatory requirements
- Provides training as necessary to enhance data quality and compliance
- Activities typically include developing the Risk-Based Quality Management and Risk-Based Monitoring using clinical trial data, ensuring key risk indicators (KRIs) and Site Performance Indicators (SPIs) properly defined and set up in the system to support the study, processing and reviewing study data in the system for the signal and action management, and follow up for the issue resolution
- Review protocols to ensure the set-up, review and reporting requirements can be met and are standardized
- Provide technical oversight, guidance and coordination for all the central monitor activities
- Define key risk indicators (KRIs) in study system, and ensure consistency between the standard level and the study level
- Ensure RBM system alignment with the protocol and adherence to ICH GCP, SOPs, corporate standards and regulatory requirements
- Work with Study Team to define issue resolution for the review of findings as signals and actions
- Develop, implement, and maintain Quality Control related documentation for RBM related activities to ensure data completeness and accuracy
- Perform central monitoring activities including review system outputs, propose suggestions for signal and action management, and follow up with study team for the action resolutions
- Ensure lessons learned during the course of the study are documented and shared with other central monitors/ study teams to facilitate cross-study learning
- Comprehensive experience in clinical monitoring, clinical data analytics and/ or data management activities
- Ability to work independently to drive RBQM activities as a change champion, keeping the teams on track to risk management and oversight activities
- Excellent communication and coordination skills strongly preferred with experience working and communicating within cross-functional teams
- Knowledge of overall clinical trial management process, understanding of the protocol, study associated risks and their significance in monitoring the clinical study
- Critical thinking and analytical skills to understand/ analyze complex data and provide insight into risk reports, trends, and outliers in data
- Therapeutic area specific experience and knowledge – CNS preferred
- Technical ability to use the relevant technology and risk-based tools/platforms effectively
- Bachelor’s degree in a scientific or health-related field
- 10 years' clinical monitoring (central monitor/lead CRA/data management) and study conduct
- Demonstrated knowledge of clinical development including knowledge and understanding of the principles of GCP, particularly in relation to risk-based monitoring, computerized systems and direct data entry
- Ability to critically analyze, interpret, and summarize output per the risk-based management monitoring plan
- Ability to manage tasks, time and priorities
- Demonstrated effective verbal and written communication skills, including the ability to communicate in a remote team environment and adapt communications to audience
- Relevant pharmaceutical industry experience
- Proficient experience using commercial clinical data management systems and/or EDC products
- Clinical trials expertise with an understanding of data operations required for the reporting of clinical trial data
- Good understanding of ICH and regulatory guidelines
- Working knowledge of clinical data and relevant data standard
- Strong written and oral communication skills, and project management skills
- Proven ability to operate with limited oversight
- Knowledge of at least 1 Therapeutic Area especially Psychiatry
- Proven ability to manage delivery under tight timelines